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Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients with Acute Lymphoblastic Leukemia

Trial Status: Active

This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.

Inclusion Criteria

  • Registration Step 1 – Induction/Re-Induction:
  • Patients must have a new morphologic diagnosis of precursor B cell acute lymphoblastic leukemia (ALL) (non T cell) based on World Health Organization (WHO) criteria; patients with Burkitt's (L3) are excluded; patients with Ph-positive or Ph-like ALL with dasatinib-sensitive mutations or kinase fusions may have relapsed or refractory diagnoses * NOTE: Relapsed/refractory Ph-positive patients or Ph-like patients with dasatinib-sensitive mutations or kinase fusions who have previous exposure to either dasatinib or another 2nd or 3rd generation tyrosine kinase inhibitor (TKI) will begin protocol therapy with Cohort 2: re-induction cycle 1
  • Patients must have a diagnosis of Philadelphia chromosome negative ALL or Ph chromosome positive ALL by cytogenetics, fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR); patients will be registered to receive treatment in either Cohort 1 (ph-) or Cohort 2 (Ph+ or Ph-like DSMKF) based on these results; diagnostic specimens must be submitted to the site’s local Clinical Laboratory Improvement Amendments (CLIA)-approved cytogenetics laboratory and results of tests (cytogenetics, FISH or PCR) must confirm Ph status prior to registration; if not already known, breakpoint cluster region- abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) status (p190 or p210) must be evaluated in Ph-positive patients by PCR * For Cohort 2, Ph-like testing is not required specifically for this study; however, to be registered to Cohort 2 under the Ph-like DSMKF criterion, the patient must have a known or presumed activating Ph-like signature and dasatinib-sensitive mutation or kinase fusion, such as: ABL1, ABL2, colony stimulating factor 1 receptor (CSF1R), platelet derived growth factor receptor beta (PDGFRB), platelet derived growth factor receptor alpha (PDGFRA), or fibroblast growth factor receptor (FGFR)s that was otherwise identified as part of normal standard of care; prior to registering any patients with a known or presumed activating Ph-like signature and dasatinib-sensitive mutations or kinase fusions (DSMKF) treating physicians must confirm eligibility with the study chairs via email; the study chairs must respond via email with confirmation of patient eligibility prior to patient registration
  • All newly diagnosed patients must have evidence of ALL in their marrow or peripheral blood with at least 20% lymphoblasts present in blood or bone marrow collected within 28 days prior to registration; all relapsed/refractory patients (Cohort 2) must have at least 5% lymphoblasts present in blood or bone marrow collected within 28 days prior to registration; for relapsed/refractory patients, pathology and cytogenetics reports (both from time of original diagnosis) must be submitted at time of registration; if a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage; for ALL in marrow or peripheral blood, immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T cell or mixed B/T cell); appropriate marker studies including cluster of differentiation (CD)19 (B cell), must be performed; co-expression of myeloid antigens (CD13 and CD33) will not exclude patients; if possible, the lineage specific markers (myeloid cells) should be determined; the blood/bone marrow sample for these assays must be obtained within 28 days prior to registration; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible
  • Patient must not have a history or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, active ALL in the CNS confirmed by cerebrospinal fluid (CSF) analysis, or other significant CNS abnormalities
  • Patients must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration; patients with CNS3 are excluded from the trial; patients with CNS1 or CNS2 will be eligible, but will be monitored for CNS involvement; note that intrathecal methotrexate administered during the pre-study lumbar puncture may count as the first dose of intrathecal therapy required as part of the study
  • Cohort I, Ph-negative Patients Only: Patients must not have received any prior chemotherapy, radiation therapy, or other therapy for the treatment of ALL (other than those noted below) and must not be receiving any immunosuppressive therapy; patients may not have received any prior investigational therapy within 28 days prior to registration; patients must not have received any monoclonal antibody therapy within 42 days of registration; patients may have received the following within any time prior to registration: low dose chemotherapy-including: cyclophosphamide 1 g/m^2, oral 6-mercaptopurine, or oral methotrexate (other low dose chemotherapy may be allowable, however any other options not listed here should be confirmed with the study chairs), TKI therapy, steroids, hydroxyurea, leukapheresis, intrathecal chemotherapy or vincristine (vincristine sulfate)
  • Cohort I, Ph-negative Patients Only: In the event that the patient’s bone marrow blast count is >= 50% blasts, patients may be registered but should receive steroids for 3-5 days in order to reduce tumor burden prior to blinatumomab administration, as follows * Prephase treatment with dexamethasone (10-20 mg/m^2) for 3-5 days is required for patients with bone marrow blasts >= 50%, peripheral blood blasts 15,000/uL or higher, or elevated lactate dehydrogenase (LDH) suggesting rapidly progressive disease per investigator opinion ** Pre-treatment should conclude at least 24 hours prior to the first dose of blinatumomab (although additional dexamethasone is automatically given as a pre-med prior to the first dose); at the time of first infusion of blinatumomab, the absolute peripheral blast count should be < 25,000/uL ** Note: For the purposes of the study, day 1 of the cycle will be the first day of blinatumomab administration
  • Cohort I, Ph-negative Patients Only: It is preferred, but not required, that corticosteroids and hydroxyurea should start only after all diagnostic samples have been obtained; however, if the patient was previously on corticosteroids and/or hydroxyurea, this is allowable provided that the patient still has measurable disease at time of the bone marrow aspirate * Corticosteroids and/or hydroxyurea, as well as any of the other therapies mentioned (with the exception of IV cyclophosphamide), may continue to be administered, at physician discretion, until 1 day prior to blinatumomab administration * IV cyclophosphamide must be discontinued at least 7 days prior to blinatumomab administration
  • Cohort 2, Ph-positive and Ph-like DSMKF Patients Only: Patients must NOT have received a prior autologous or allogeneic hematopoietic stem cell transplant at any time. Patients must NOT have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration, with the following exceptions: * Monoclonal antibodies must not have been received for 1 week prior to registration * Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration * Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any timeframe prior to registration; Food and Drug Administration (FDA)-approved TKIs may also be administered until 1 day prior to start of study therapy (C1, D1); IV cyclophosphamide may be administered at doses of 1 g/m^2 or less until up to 7 days prior to registration
  • Patients must be >= 65 years of age; for patients 65-69 years of age, patient must be deemed not suitable for standard intensive induction chemotherapy at the discretion of the local investigator, or must have refused standard intensive chemotherapy
  • Cohort I, Ph-negative Patients Only: Patients must not be candidates for allogeneic hematopoietic stem cell transplant; NOTE: Subjects up to age 70 years who are considered fit for allogeneic hematopoietic stem cell transplant, should be considered for enrollment on E1910, in order to avoid competing with that study; if a patient is considered unfit for intensive chemotherapy at the time of initial diagnosis, but subsequently achieves a complete remission (CR), then it will be left to the treating physician’s discretion to consider hematopoietic stem cell transplant (HSCT)
  • Patients must have complete history and physical examination within 28 days prior to registration
  • Patients must have a Zubrod performance status of 0-2
  • Patients must have serum creatinine =< 1.5 mg/dl within 14 days prior to registration
  • Patients must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
  • Patients must have total bilirubin =< 2.0 x IULN within 14 days prior to registration
  • Patients must have alkaline phosphatase =< 2.5 x IULN within 14 days prior to registration
  • Patients must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
  • Patients must not have Common Terminology Criteria for Adverse Events (CTCAE) >= grade 2 neuropathy (cranial, motor or sensory) within 14 days prior to registration
  • Patients known to be positive for HIV (the human immunodeficiency virus) may be eligible, providing they meet the following additional criteria within 28 days prior to registration: * No history of acquired immune deficiency syndrome (AIDS)-defining conditions * CD4 cells > 350 cells/mm^3 * If on antiretroviral agents, must not include zidovudine or stavudine * Viral load =< 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or =< 25,000 copies HIV mRNA/mm^3 if not on cART * Highly active antiretroviral therapy (HAART) regimens are acceptable providing they have only weak P450A4 interactions
  • Patients must not have any known autoimmune disease
  • Patients must not have testicular involvement; if clinical or ultrasound findings are equivocal, biopsy must be performed; all tests for establishing testicular involvement must be completed within 14 days prior to registration
  • Patients with evidence of extramedullary disease at diagnosis will have computed tomography (CT) scan or magnetic resonance imaging (MRI) of the chest, abdomen and pelvis to obtain baseline values within 28 days prior to registration
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • Patients must have the following tests within 28 days prior to registration to obtain baseline measurements: * Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR)/fibrinogen (all patients) * Cohort 1, Ph- Patients Only: Neurologic assessment
  • Cohort 2, Ph+ and Ph-like DSMKF Patients Only: Patients must not have active pericardial effusion, ascites or pleural effusion of any grade based on chest x-ray and echocardiogram within 28 days prior to registration; exception: if the effusion is suspected to be related to the leukemia, the patient may have pericardial effusion =< grade 2 or pleural effusion =< grade 1
  • Cohort 2, Ph+ and Ph-like DSMKF Patients Only: Patients must have ejection fraction >= 45% based on echocardiogram performed within 28 days prior to registration
  • Cohort 2, Ph+ and Ph-like DSMKF Patients Only: Patients must have QTcF (by Fridericia calculation) < 480/msec based on electrocardiogram (EKG) performed within 28 days prior to registration
  • Cohort 2, Ph+ and Ph-like DSMKF Patients Only: Patients must not be receiving any proton pump inhibitors at the time of registration
  • Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 28 days prior to registration to S1318; specimens must be submitted to the site’s preferred CLIA-approved cytogenetics laboratory; BCR-ABL status must be verified in Ph-positive patients by FISH, cytogenetics, and/or PCR prior to enrollment; if a patient is Ph-positive, PCR for both p190 and p210 must be sent
  • Patients must be offered participation in specimen submission for future research; with patient’s consent, specimens must be submitted as outlined
  • Cohort 1, Ph-negative patients only: Patients must have specimens submitted for blinatumomab immunogenicity assessment; collection of pretreatment specimens must be completed within 28 days prior to registration to S1318; specimens must be submitted to LabConnect
  • Cohort 2, Ph-positive and Ph-like DSMKF patients only: Patients must agree to have specimens submitted for blinatumomab immunogenicity testing if subsequently moved to a blinatumomab containing treatment regimen on protocol
  • Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Registration Step 2 – Post-Remission Therapy:
  • COHORT 1 PH-NEGATIVE PATIENTS ONLY: Patients must have achieved CR or CRi within 2 cycles of induction/re-induction with blinatumomab * NOTE: day 1 of post-remission = day 43 of the preceding cycle (+/- 3 days)
  • COHORT 2 PH-POSITIVE AND PH-LIKE DSMKF PATIENTS ONLY: Newly diagnosed Ph+, newly-diagnosed Ph-like DSMKF, and relapsed/refractory Ph+ patients without prior dasatinib or other 2nd or 3rd generation TKI therapy, must have achieved CR or CRi within 1 cycle of induction with dasatinib/prednisone, or within 2 cycles of re-induction with blinatumomab; relapsed/refractory Ph+ or Ph-like DSMKF patients with prior dasatinib or other 2nd or 3rd generation TKI therapy must have achieved CR or CRi within 2 cycles of re-induction therapy with blinatumomab * NOTE: day 1 of post-remission = day 85 of the preceding induction cycle (+/- 3 days), or day 43 of the preceding re-induction cycle (+/- 3 days) as applicable
  • Serum creatinine =< 1.5 mg/dl within 14 days prior to registration
  • AST and ALT =< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
  • Total bilirubin =< 2.0 x IULN within 14 days prior to registration
  • Absolute neutrophil count (ANC) >= 750/mcL within 28 days prior to registration
  • Platelets >= 50,000/mcL within 28 days prior to registration
  • Patients must be registered to Step 2 within 28 days after count recovery; (Note: there is no maximum allotted time period for count recovery, providing patient remains in CR or CRi)
  • All non-hematologic treatment related toxicities that are deemed clinically significant by the treating investigator must have resolved to =< grade 2
  • Registration Step 3 – Maintenance: Patients must have documented CR or CRi within 28 days prior to registration; note that bone marrow examination is only required if there are clinical signs/symptoms of progression; if progression is a concern due to the length of the time for count recovery, a bone marrow examination is recommended
  • Registration Step 3 – Maintenance: Patients must have serum creatinine =< 1.5 mg/dl within 14 days prior to registration
  • Registration Step 3 – Maintenance: Patients must have AST and ALT =< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
  • Registration Step 3 – Maintenance: Patients must have total bilirubin < 2.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
  • Registration Step 3 – Maintenance: Patients must have adequate marrow function as evidenced by ANC >= 750/mcL within 28 days prior to registration
  • Registration Step 3 – Maintenance: Patients must have adequate marrow function as evidenced by platelets >= 75,000/mcL within 28 days prior to registration
  • Registration Step 3 – Maintenance: All non-hematologic treatment related toxicities that are deemed clinically significant by the treating investigator must have resolved to =< grade 2

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 205-934-0220

Arizona

Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
University of Arizona Cancer Center-North Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-327-2873

Arkansas

Little Rock
John L McClellan Memorial Veterans Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 501-257-5583

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-826-4673
La Jolla
UC San Diego Moores Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 858-822-5354
Loma Linda
Loma Linda University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 909-558-3375
Los Angeles
Los Angeles County-USC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
Newport Beach
USC Norris Oncology / Hematology-Newport Beach
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-827-8839
Pasadena
Keck Medical Center of USC Pasadena
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451

Connecticut

New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702
Yale University
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702

Florida

Orlando
UF Cancer Center at Orlando Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 321-841-7246

Georgia

Atlanta
Northside Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 404-303-3355
Augusta
Augusta University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 706-721-2388

Illinois

Aurora
Rush - Copley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212
Bloomington
Illinois CancerCare-Bloomington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Saint Joseph Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-457-5200
Carthage
Illinois CancerCare-Carthage
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
University of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-355-3046
Danville
Carle on Vermilion
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Carle Physician Group-Effingham
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Eureka
Illinois CancerCare-Eureka
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-242-4600
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Radiation Oncology of Northern Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Central Illinois Hematology Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-525-2500
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Yorkville
Rush-Copley Healthcare Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212

Indiana

Indianapolis
Franciscan Health Indianapolis
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-528-7060
Michigan City
Franciscan Saint Anthony Health-Michigan City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-931-3322
Woodland Cancer Care Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 219-861-5800
Richmond
Reid Health
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900

Iowa

Ames
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-239-4734
Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Jefferson
McFarland Clinic PC-Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Sioux City
Siouxland Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 712-252-9326

Kansas

Chanute
Cancer Center of Kansas - Chanute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Dodge City
Cancer Center of Kansas - Dodge City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
El Dorado
Cancer Center of Kansas - El Dorado
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Fort Scott
Cancer Center of Kansas - Fort Scott
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Independence
Cancer Center of Kansas-Independence
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-588-3671
Kingman
Cancer Center of Kansas-Kingman
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Lawrence
Lawrence Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Liberal
Cancer Center of Kansas-Liberal
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
McPherson
Cancer Center of Kansas - McPherson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Newton
Cancer Center of Kansas - Newton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Parsons
Cancer Center of Kansas - Parsons
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Pratt
Cancer Center of Kansas - Pratt
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Salina
Cancer Center of Kansas - Salina
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Wellington
Cancer Center of Kansas - Wellington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-588-3671
Wichita
Ascension Via Christi Hospitals Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-362-0070
Associates In Womens Health
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas - Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Wesley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Winfield
Cancer Center of Kansas - Winfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374

Kentucky

Crestview Hills
Oncology Hematology Care Inc-Crestview
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-416-9270

Louisiana

Shreveport
LSU Health Sciences Center at Shreveport
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 318-813-1404

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-888-8823

Michigan

Adrian
Hickman Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 517-265-0116
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Battle Creek
Bronson Battle Creek
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Farmington Hills
Beaumont Hospital - Farmington Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
Weisberg Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Grand Rapids
Mercy Health Saint Mary's
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Grosse Pointe
William Beaumont Hospital-Grosse Point
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
Kalamazoo
Borgess Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Monroe
Toledo Clinic Cancer Centers-Monroe
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-444-3561
Muskegon
Mercy Health Mercy Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Niles
Lakeland Hospital Niles
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Reed City
Spectrum Health Reed City Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Royal Oak
William Beaumont Hospital-Royal Oak
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Traverse City
Munson Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Troy
William Beaumont Hospital - Troy
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-333-5000
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Bolivar
Central Care Cancer Center - Bolivar
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Bonne Terre
Parkland Health Center-Bonne Terre
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Branson
Cox Cancer Center Branson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-651-5550
Jefferson City
Capital Region Southwest Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-632-4814
Joplin
Freeman Health System
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-556-3074
Rolla
Delbert Day Cancer Institute at PCRMC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-6379
Saint Louis
Mercy Hospital Saint Louis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-7066
Missouri Baptist Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-353-1870
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569

Nebraska

Bellevue
Nebraska Medicine-Bellevue
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941
Omaha
Nebraska Medicine-Village Pointe
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-5600
University of Nebraska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355
Lake Success
Northwell Health / Center for Advanced Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 516-734-8896
Manhasset
North Shore University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 516-734-8896
New Hyde Park
Long Island Jewish Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 516-734-8896
Rochester
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-275-3853
Kenansville
Vidant Oncology-Kenansville
Status: ACTIVE
Contact: Site Public Contact
Phone: 252-559-2201
Kinston
Vidant Oncology-Kinston
Status: ACTIVE
Contact: Site Public Contact
Phone: 252-559-2201
Richlands
Vidant Oncology-Richlands
Status: ACTIVE
Contact: Site Public Contact
Phone: 252-559-2201
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Clinic North-Fargo
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Preston D. Steen
Phone: 712-252-0088
Sanford Roger Maris Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Centerville
Miami Valley Hospital South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Cincinnati
Oncology Hematology Care Inc-Anderson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-416-9270
Oncology Hematology Care Inc-Blue Ash
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-416-9270
Oncology Hematology Care Inc-Eden Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-416-9270
Oncology Hematology Care Inc-Kenwood
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Oncology Hematology Care Inc-Mercy West
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-416-9270
Cleveland
Case Western Reserve University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Dayton
Good Samaritan Hospital - Dayton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-416-9270
Miami Valley Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Miami Valley Hospital North
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Fairfield
Oncology Hematology Care Inc-Healthplex
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-416-9270
Findlay
Blanchard Valley Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Franklin
Atrium Medical Center-Middletown Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Greenville
Wayne Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Kettering
Kettering Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Maumee
Toledo Clinic Cancer Centers-Maumee
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-444-3561
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-891-5600ext4
Oregon
Saint Charles Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-696-7200
Springfield
Springfield Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Springfield Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Toledo
Mercy Saint Anne Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-407-1160
Toledo Clinic Cancer Centers-Toledo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-444-3561
Troy
Upper Valley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
WPAFB
Wright-Patterson Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Portland
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-955-6084
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-474-9892

South Carolina

Easley
Prisma Health Cancer Institute - Easley
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Greenville
Greenville Health System Cancer Institute-Andrews
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-241-6251
Prisma Health Cancer Institute - Butternut
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Greenville Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Greer
Prisma Health Cancer Institute - Greer
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066

Texas

Dallas
Baylor University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-422-9567

Wisconsin

Green Bay
Green Bay Oncology Limited at Saint Mary's Hospital
Status: ACTIVE
Contact: Brian Leslie Burnette
Phone: 920-433-8889
Green Bay Oncology at Saint Vincent Hospital
Status: ACTIVE
Contact: Brian Leslie Burnette
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center Green Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Milwaukee
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666

PRIMARY OBJECTIVES:

I. To evaluate the 3-year survival rate in elderly patients with newly diagnosed Philadelphia (Ph)-negative acute lymphoblastic leukemia (ALL) treated with blinatumomab followed by POMP (prednisone, vincristine sulfate, methotrexate, and mercaptopurine) maintenance.

II. To evaluate in a preliminary manner (feasibility study) the safety of dasatinib-steroid based induction followed by blinatumomab treatment in combination with dasatinib followed by dasatinib-based maintenance in patients with newly diagnosed Ph-positive ALL, relapsed/refractory Ph-positive ALL, and Ph-like dasatinib-sensitive mutations or kinase fusions (DSMKF) ALL (newly-diagnosed relapsed or refractory).

SECONDARY OBJECTIVES:

I. To evaluate toxicities in these patient populations treated with these regimens.

II. To estimate the rates of complete response (CR), complete remission with incomplete count recovery (CRi) and disease-free survival in Ph-negative patients.

III. To estimate disease-free and overall survival in Ph-positive ALL and Ph-like DSMKF ALL.

IV. To estimate in each cohort the rate of minimal residual disease (MRD) negativity, and the time to achieve MRD negativity (exploratory analysis).

V. To determine whether anti-idiotype antibodies directed against blinatumomab develop with blinatumomab treatment in this study.

ADDITIONAL TRANSLATIONAL MEDICINE OBJECTIVES:

I. To estimate the incidence of the Ph-like signature in elderly patients (>= 65 years of age) with newly diagnosed Philadelphia-chromosome negative ALL.

II. To estimate the incidence of the various tyrosine-kinase fusions, making up the Ph-like signature in elderly patients with newly diagnosed Philadelphia-chromosome negative ALL.

III. To evaluate outcomes (event free survival [EFS] and overall survival [OS]) in patients with the Ph-like signature versus those without the Ph-like signature in Ph-negative ALL.

OUTLINE: Patients are assigned to 1 of 2 treatment cohorts according to Philadelphia chromosome status.

COHORT I (PHILADELPHIA CHROMOSOME NEGATIVE PATIENTS):

INDUCTION: Patients receive blinatumomab intravenously (IV) continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17)

RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity.

POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive prednisone orally (PO) on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity.

COHORT II (PHILADELPHIA CHROMOSOME POSITIVE PATIENTS):

INDUCTION: Patients receive dasatinib PO twice daily (BID) on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity.

RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity.

POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO once daily (QD) on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually until 10 years from initial registration.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
SWOG

Principal Investigator
Anjali S. Advani

  • Primary ID S1318
  • Secondary IDs NCI-2014-01047, SWOG-S1318
  • Clinicaltrials.gov ID NCT02143414