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Venetoclax and Vincristine Liposomal in Treating Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

Trial Status: Active

This phase Ib / II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine liposomal in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as vincristine liposomal, 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. Giving venetoclax together with vincristine liposomal may work better in treating patients with acute lymphoblastic leukemia compared to vincristine liposomal alone.

Inclusion Criteria

  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 0: Patient must be considered a potential candidate for the trial * NOTE: Enrollment to Step 0 may occur prior to or following completion of the assessments to verify patient eligibility for Step 1 registration; bone marrow and/or peripheral blood specimens collected during Step 0 or prior to treatment on Step 1 must be submitted for central review in order for the patient to be considered evaluable; results will not be reported to the site and will not impact patient participation in the trial
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must have a diagnosis of: * Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy * Patients with < 5% blasts may enroll on trial in phase I portion provided that minimal residual disease (MRD) is present at > 10^-3 as tested on an assay with minimum sensitivity of 10^-4 OR * Relapsed lymphoblastic lymphoma
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Adequate liver function with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 3 x upper limit of normal and total bilirubin less than 2 mg/dL within 10 days prior to first dose of study agent
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Circulating white blood cell (WBC) count must not be above 25 x 10^9/L at the time of registration * Patients with WBC count above 25 x 10^9/L are eligible if they have started steroids or hydroxyurea per institutional guidelines
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Glomerular filtration rate (GFR) of at least 40 mL/min within 7 days prior to first dose of study agent
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: All females of childbearing potential must have a blood test or urine study with a minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG) within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Women of childbearing potential and sexually active males must use an accepted and highly effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 2 years so as not to interfere with interpretation of radiographic response
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patient may be enrolled with a prior allogeneic hematopoietic stem cell transplant (HSCT) but the transplant date must be at least 90 days before date of registration to step 1; patient must be off immunosuppression and without active graft versus host disease (GVHD) prior to registration to step 1 if previous HSCT
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 0: Patient must be considered a potential candidate for the trial * NOTE: Enrollment to Step 0 may occur prior to or following completion of the assessments to verify patient eligibility for Step 1 registration; bone marrow and/or peripheral blood specimens collected during Step 0 or prior to treatment on Step 1 must be submitted for central review in order for the patient to be considered evaluable; results will not be reported to the site and will not impact patient participation in the trial
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Relapsed or refractory B-cell or T-cell ALL, including lymphoblastic lymphoma, after multi-agent chemotherapy
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: ECOG performance status 0-2
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Adequate liver function with AST/ALT less than 3 x upper limit of normal and total bilirubin less than 2 mg/dL within 10 days prior to first dose of study agent
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Circulating WBC count must not be above 25 x 10^9/L at the time of registration to step 1 * Patients with WBC count above 25 x 10^9/L are eligible if they have started steroids or hydroxyurea per institutional guidelines
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: GFR of at least 40 mL/min within 7 days prior to first dose of study agent
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: All females of childbearing potential must have a blood test or urine study with a minimum sensitivity 25 IU/L or equivalent units of HCG within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Women of childbearing potential and sexually active males must use an accepted and highly effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patient may be enrolled with a prior allogeneic hematopoietic stem cell transplant (HSCT) but the transplant date must be at least 90 days before date of enrollment; patient must be off immunosuppression and without active GVHD prior to enrollment if previous HSCT

Exclusion Criteria

  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Women must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with isolated testicular or central nervous system (CNS) relapsed disease are not eligible
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patient must not have Burkitt’s lymphoma/leukemia based on the World Health Organization (WHO) criteria
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or the use of CNS-directed local treatment for active disease within the prior 28 days; prophylactic intrathecal chemotherapy is allowed; previously treated CNS disease with documented clearance of the CSF will be allowed
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients will not be enrolled if they received prior chemotherapy within 2 weeks before registration to step 1 with the following exceptions: to reduce the circulating lymphoblast count or palliation or for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patient cannot have poorly controlled chronic viral infections including hepatitis B, C, or human immunodeficiency virus (HIV); HIV positive patients are allowed on this study if they have a CD4 count >= 400, and are on a stable antiviral regimen
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not be taking any other experimental medications within 21 days prior to registration. Clinical trial medications that are Food and Drug Administration (FDA) approved will be allowed within 14 days prior to registration
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients should not have received the following within 7 days prior to the first dose of study drug: * Strong and moderate CYP3A inhibitors; * Strong and moderate CYP3A inducers
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not have grade 3 or higher peripheral neuropathy or history of grade 3 or higher peripheral neuropathy. Patients with familial demyelinating disease like Charcot-Marie-Tooth disease are also excluded
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Women must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 2 years
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with isolated testicular or CNS relapsed disease are not eligible
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patient must not have Burkitt’s lymphoma/leukemia based on the WHO criteria
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or the use of CNS-directed local treatment for active disease within the prior 28 days; prophylactic intrathecal chemotherapy is allowed; previously treated CNS disease with documented clearance of the CSF will be allowed and once cleared, prophylactic intrathecal chemotherapy can be continued
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea), for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patient cannot have poorly controlled chronic viral infections including hepatitis B, C, or HIV; HIV positive patients are allowed on this study if they have a CD4 count >= 400, and are on a stable antiviral regimen
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients should not have received the following within 7 days prior to the first dose of study drug: * Strong and moderate CYP3A inhibitors; * Strong and moderate CYP3A inducers
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have grade 3 or higher peripheral neuropathy history of grade 3 peripheral neuropathy; patients with familial demyelinating diseases like Charcot-Marie-Tooth disease also excluded

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Oncology and Hematology LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Women's Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Associates in Radiation Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Radiation Therapy Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: CLOSED_TO_ACCRUAL
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Phone: 907-212-6871
Providence Alaska Medical Center
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Phone: 907-212-6871

Arizona

Phoenix
Mayo Clinic Hospital in Arizona
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Scottsdale
Mayo Clinic in Arizona
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Arkansas

Ft. Smith
Mercy Hospital Fort Smith
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Phone: 800-378-9373

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 818-847-4793

Connecticut

Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702
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

Jacksonville
Mayo Clinic in Florida
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015

Idaho

Boise
Saint Luke's Cancer Institute - Boise
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-2774
Fruitland
Saint Luke's Cancer Institute - Fruitland
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Contact: Site Public Contact
Phone: 208-381-2774
Meridian
Saint Luke's Cancer Institute - Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-2774
Nampa
Saint Luke's Cancer Institute - Nampa
Status: CLOSED_TO_ACCRUAL
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Phone: 208-381-2774
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
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Illinois

Alton
Saint Anthony's Health
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Bloomington
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Canton
Illinois CancerCare-Canton
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Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
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Phone: 618-457-5200
Carterville
SIH Cancer Institute
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Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
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Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Chicago
Northwestern University
Status: ACTIVE
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Phone: 312-695-1301
Decatur
Cancer Care Specialists of Illinois - Decatur
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Phone: 217-876-4762
Decatur Memorial Hospital
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Phone: 217-876-4762
Dixon
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Phone: 815-285-7800
Effingham
Crossroads Cancer Center
Status: ACTIVE
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Phone: 217-876-4762
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
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Phone: 309-243-3605
Western Illinois Cancer Treatment Center
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Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
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Phone: 309-243-3605
Macomb
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Phone: 309-243-3605
Mount Vernon
Good Samaritan Regional Health Center
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Phone: 618-242-4600
O'Fallon
Cancer Care Center of O'Fallon
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Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
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Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
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Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
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Phone: 309-243-3605
Methodist Medical Center of Illinois
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Phone: 309-243-3605
OSF Saint Francis Medical Center
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Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Phone: 309-243-3605
Peru
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Phone: 309-243-3605
Valley Radiation Oncology
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Phone: 815-664-4141
Princeton
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Phone: 309-243-3605
Springfield
Memorial Medical Center
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Phone: 217-528-7541
Southern Illinois University School of Medicine
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Phone: 217-545-7929
Springfield Clinic
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Phone: 800-444-7541
Washington
Illinois CancerCare - Washington
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Phone: 309-243-3605

Kansas

Garden City
Central Care Cancer Center - Garden City
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-948-5588
Great Bend
Central Care Cancer Center - Great Bend
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-948-5588

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-955-8804

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Missouri

Ballwin
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Contact: Site Public Contact
Phone: 314-251-7058
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Central Care Cancer Center - Bolivar
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Contact: Site Public Contact
Phone: 913-948-5588
Branson
Cox Cancer Center Branson
Status: ACTIVE
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
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Phone: 573-651-5550
Farmington
Parkland Health Center - Farmington
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Phone: 314-996-5569
Jefferson City
Capital Region Southwest Campus
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Phone: 573-632-4814
Joplin
Freeman Health System
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Phone: 417-347-4030
Mercy Hospital Joplin
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Phone: 417-556-3074
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-7504
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
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Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
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Phone: 816-271-7937
Saint Louis
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Phone: 314-251-7066
Mercy Hospital South
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Missouri Baptist Medical Center
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Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
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Phone: 314-353-1870
Sainte Genevieve
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Phone: 314-996-5569
Springfield
CoxHealth South Hospital
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Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
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Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
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Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
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Phone: 314-996-5569
Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Missoula
Saint Patrick Hospital - Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-327-3118

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-7356

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402

Oregon

Bend
Saint Charles Health System
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Portland
Providence Portland Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Redmond
Saint Charles Health System-Redmond
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-706-2909

Pennsylvania

Hershey
Penn State Milton S Hershey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-531-3779
Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-600-9151
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-474-9892

South Carolina

Greenville
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-788-8238
Centralia
Providence Regional Cancer System-Centralia
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Edmonds
Swedish Cancer Institute-Edmonds
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Everett
Providence Regional Cancer Partnership
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 425-261-3529
Issaquah
Swedish Cancer Institute-Issaquah
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Kennewick
Kadlec Clinic Hematology and Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 509-783-4637
Lacey
Providence Regional Cancer System-Lacey
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Longview
PeaceHealth Saint John Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-2016
Seattle
Pacific Gynecology Specialists
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Ballard Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Cherry Hill
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-First Hill
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Sedro-Woolley
PeaceHealth United General Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-788-8238
Shelton
Providence Regional Cancer System-Shelton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Vancouver
PeaceHealth Southwest Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 509-897-5993
Yelm
Providence Regional Cancer System-Yelm
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958

Wisconsin

Milwaukee
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose of venetoclax in combination with vincristine liposomal (liposomal vincristine) in patients with relapsed or refractory T-cell and B-cell acute lymphoblastic leukemia (ALL). (Phase I)

II. Safety assessment and toxicity characterization after treatment of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory T-cell and B-cell ALL. (Phase I)

III. To determine the preliminary efficacy of venetoclax in combination with liposomal vincristine to induce complete remission (CR)+ incomplete complete remission (CRi) in patients with relapsed or refractory T-cell and B-cell ALL. (Phase II)

SECONDARY OBJECTIVES:

I. To determine the progression free survival, overall survival and toxicity after the combination treatment in patients with relapsed or refractory T-cell and B-cell ALL. (Phase II)

II. To determine the rate of minimal residual disease (MRD) negativity rate of the combination. (Phase II)

EXPLORATORY/CORRELATIVE OBJECTIVES:

I. To determine if genetic signature as determined by next generation sequencing can predict response to combination. (Phase II)

II. To determine if immunophenotype of ALL is associated with response to combination. (Phase II)

III. To determine if the BH3 profile is associated with response to combination. (Phase II)

IV. To determine if relative expression of BCL-2 measure by flow cytometry is associated with response to combination. (Phase II)

OUTLINE: This is a phase Ib, dose-escalation study of venetoclax followed by a phase II study.

PHASE Ib: Patients receive venetoclax orally (PO) once daily (QD) on days 1-42 of cycle 1 and days 43-70 of cycle 2. Patients also receive vincristine liposomal intravenously (IV) over 1 hour weekly for 4 weeks starting on day 15 of cycle 1. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients receive venetoclax PO QD on days 1-28 and vincristine liposomal IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 cycles. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 5 years.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Neil David Palmisiano

  • Primary ID EA9152
  • Secondary IDs NCI-2017-01158
  • Clinicaltrials.gov ID NCT03504644