Tretinoin and Arsenic Trioxide in Treating Patients with Untreated Acute Promyelocytic Leukemia

Status: Active

Description

This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.

Eligibility Criteria

Inclusion Criteria

  • Patients must be newly diagnosed with a clinical diagnosis of APL (initially by morphology of bone marrow or peripheral blood) * Bone marrow is highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral blood will be accepted
  • If the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate the PML-RARalpha transcript by RQ-PCR to be eligible
  • NOTE: A lumbar puncture is not required in order to be enrolled on study nor are lumbar punctures recommended at the time of diagnosis; if the diagnosis of APL is known or suspected, diagnostic lumbar punctures in patients with neurologic symptoms should be deferred until any coagulopathy is corrected; if central nervous system (CNS) disease is suspected or proven, a computed tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out the possibility of an associated chloroma; if CNS disease is documented, patients are still eligible and will receive protocol directed intrathecal treatments
  • Patients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to administration of protocol therapy
  • Treatment with hydroxyurea, corticosteroids (any route) and intrathecal cytarabine prior to beginning protocol directed therapy is allowed; however, it should be noted that lumbar puncture and intrathecal therapy at initial diagnosis of APL is not recommended
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

  • Patients with secondary APL are excluded; this includes all patients with APL that may have resulted from prior treatment (chemotherapy or radiation)
  • Patients with isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) but without evidence of APL by bone marrow or peripheral blood morphology are excluded
  • Patients with a pre-existing diagnosis of a prolonged QT syndrome (even if corrected QT interval [QTc] is normal at the time of APL diagnosis) are excluded
  • Patients with a baseline QTc of > 450 msec are excluded; Bazett’s formula is to be used for measurement of the corrected QT interval: the QT interval (msec) divided by the square root of the RR interval (msec)
  • Patients with a history or presence of significant ventricular or atrial tachyarrhythmia are excluded
  • Patients with right bundle branch block plus left anterior hemiblock, bifascicular block are excluded
  • Patients with serum creatinine > 3.0 mg/dL and patients on active dialysis for renal dysfunction are excluded
  • Patients who have received treatment with any other cytotoxic chemotherapy prior to beginning protocol therapy (other than allowed in above criteria) are excluded
  • Female patients who are pregnant are excluded; patients should not be pregnant or plan to become pregnant while on treatment; a pregnancy test prior to enrollment is required for female patients of childbearing potential
  • Lactating females who plan to breastfeed their infants are excluded
  • Sexually active patients of reproductive potential who have not agreed to be abstinent or use 2 forms of effective contraception during treatment through 1 month off therapy are excluded

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Mobile
University of South Alabama
Status: Active
Contact: Site Public Contact
Phone: 251-665-8000

Alaska

Anchorage
Providence Alaska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Mesa
Cardon Children's Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Phoenix
Phoenix Childrens Hospital
Status: Active
Contact: Site Public Contact
Phone: 602-546-0920

Arkansas

Little Rock
Arkansas Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

California

Downey
Kaiser Permanente Downey Medical Center
Status: Active
Contact: Site Public Contact
Phone: 626-564-3455
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673 Email: becomingapatient@coh.org
Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 909-558-3375
Los Angeles
Cedars Sinai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 310-423-8965
Children's Hospital Los Angeles
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Madera
Valley Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Kaiser Permanente-Oakland
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691 Email: Kpoct@kp.org
Orange
Children's Hospital of Orange County
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
San Diego
Rady Children's Hospital - San Diego
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
San Francisco
UCSF Medical Center-Mission Bay
Status: Active
Contact: Site Public Contact
Phone: 877-827-3222
Torrance
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Status: Active
Contact: Site Public Contact
Phone: 310-222-3621

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 302-651-6884 Email: dperry@nemours.org

District of Columbia

Washington
Children's National Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Florida

Fort Lauderdale
Broward Health Medical Center
Status: Active
Contact: Site Public Contact
Phone: 954-355-5346
Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Miami
Nicklaus Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 321-843-2584 Email: melissa.leffin@orlandohealth.com
Florida Hospital Orlando
Status: Active
Contact: Site Public Contact
Phone: 407-303-2090 Email: FH.Cancer.Research@flhosp.org
Nemours Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Temporarily closed to accrual
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Tampa General Hospital
Status: Active
Contact: Site Public Contact
Phone: 813-844-7829 Email: syapchanyk@tgh.org
West Palm Beach
Saint Mary's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Savannah
Memorial Health University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 912-350-7887 Email: clayter1@memorialhealth.com

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: Active
Contact: Site Public Contact
Phone: 808-983-6090

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222 Email: cancerclinicaltrials@bsd.uchicago.edu
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Peoria
Saint Jude Midwest Affiliate
Status: Active
Contact: Site Public Contact
Phone: 888-226-4343
Springfield
Southern Illinois University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Site Public Contact
Phone: 317-338-2194 Email: research@stvincent.org

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712 Email: Gregory.Johnstone@ochsner.org

Maine

Bangor
Eastern Maine Medical Center
Status: Active
Contact: Site Public Contact
Phone: 207-973-4274
Scarborough
Maine Children's Cancer Program
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804 Email: jhcccro@jhmi.edu
Sinai Hospital of Baltimore
Status: Active
Contact: Site Public Contact
Phone: 410-601-6120 Email: pridgely@lifebridgehealth.org
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-888-8823
Bethesda
Walter Reed National Military Medical Center
Status: Active
Contact: Site Public Contact
Phone: 301-319-2100

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-726-5130
Springfield
Baystate Medical Center
Status: Active
Contact: Site Public Contact
Phone: 413-794-3565 Email: tamara.wrenn@baystatehealth.org
Worcester
University of Massachusetts Medical School
Status: Active
Contact: Site Public Contact
Phone: 508-856-3216 Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790 Email: ctoadmin@karmanos.org
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Kalamazoo
Bronson Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
University of Minnesota / Masonic Cancer Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

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

Missouri

Kansas City
The Childrens Mercy Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-6770
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Nevada

Las Vegas
Children's Specialty Center of Nevada II
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Summerlin Hospital Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013 Email: research@sncrf.org
University Medical Center of Southern Nevada
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013 Email: research@sncrf.org

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-639-6918 Email: cancer.research.nurse@dartmouth.edu

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: Active
Contact: Site Public Contact
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Active
Contact: Site Public Contact
Phone: 732-235-8675
Newark
Newark Beth Israel Medical Center
Status: Active
Contact: Site Public Contact
Phone: 973-926-7230
Paterson
Saint Joseph's Regional Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

New York

Albany
Albany Medical Center
Status: Active
Contact: Site Public Contact
Phone: 518-262-5513
Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866 Email: aaraiza@montefiore.org
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355 Email: askroswell@roswellpark.org
Mineola
NYU Winthrop Hospital
Status: Active
Contact: Site Public Contact
Phone: 516-663-3115
New York
Columbia University / Herbert Irving Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-305-6361 Email: nr2616@cumc.columbia.edu
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Mount Sinai Hospital
Status: Active
Contact: Site Public Contact
Phone: 212-824-7309 Email: CCTO@mssm.edu
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476
Valhalla
New York Medical College
Status: Active
Contact: Site Public Contact
Phone: 914-594-3794

North Carolina

Asheville
Mission Hospital Inc-Memorial Campus
Status: Active
Contact: Site Public Contact
Phone: 828-213-4150 Email: leslie.verner@msj.org
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 704-355-2884
Novant Health Presbyterian Medical Center
Status: Active
Contact: Site Public Contact
Phone: 704-384-5369 Email: nnechiporchik@novanthealth.org
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853
Greenville
East Carolina University
Status: Active
Contact: Site Public Contact
Phone: 252-744-1015 Email: eubankss@ecu.edu
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-437-4010

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Cleveland
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100 Email: CancerAnswer@ccf.org
Rainbow Babies and Childrens Hospital
Status: Active
Contact: Site Public Contact
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Dayton
Dayton Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Toledo
The Toledo Hospital / Toledo Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Oregon Health and Science University
Status: Active
Contact: Site Public Contact
Phone: 503-494-1080 Email: trials@ohsu.edu

Pennsylvania

Hershey
Penn State Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Saint Christopher's Hospital for Children
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Puerto Rico

Caguas
HIMA San Pablo Oncologic Hospital
Status: Active
Contact: Site Public Contact
Phone: 787-653-3434
San Juan
San Jorge Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
University Pediatric Hospital
Status: Active
Contact: Site Public Contact
Phone: 787-474-0333

Rhode Island

Providence
Rhode Island Hospital
Status: Active
Contact: Site Public Contact
Phone: 401-444-1488

South Carolina

Greenville
BI-LO Charities Children's Cancer Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320 Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Knoxville
East Tennessee Childrens Hospital
Status: Active
Contact: Site Public Contact
Phone: 865-541-8266
Memphis
St. Jude Children's Research Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Nashville
The Children's Hospital at TriStar Centennial
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Corpus Christi
Driscoll Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Dallas
Medical City Dallas Hospital
Status: Active
Contact: Site Public Contact
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097 Email: canceranswerline@UTSouthwestern.edu
Fort Worth
Cook Children's Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 713-798-1354 Email: burton@bcm.edu
Lubbock
University Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
San Antonio
Children's Hospital of San Antonio
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Methodist Children's Hospital of South Texas
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Site Public Contact
Phone: 210-450-3800 Email: phoresearchoffice@uthscsa.edu

Utah

Salt Lake City
Primary Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Virginia

Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Site Public Contact
Phone: 703-208-6650 Email: Stephanie.VanBebber@inova.org
Norfolk
Children's Hospital of The King's Daughters
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Roanoke
Carilion Clinic Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Washington

Seattle
Seattle Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Tacoma
Madigan Army Medical Center
Status: Active
Contact: Site Public Contact
Phone: 253-968-0129 Email: mamcdci@amedd.army.mil
Mary Bridge Children's Hospital and Health Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

West Virginia

Morgantown
West Virginia University Healthcare
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Clinic
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581 Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Children's Hospital of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-955-4727 Email: MACCCTO@mcw.edu

Manitoba

Winnipeg
CancerCare Manitoba
Status: Active
Contact: Site Public Contact
Phone: 866-561-1026 Email: CIO_Web@cancercare.mb.ca

Nova Scotia

Halifax
IWK Health Centre
Status: Active
Contact: Site Public Contact
Phone: 902-470-6767

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Ottawa
Children's Hospital of Eastern Ontario
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Toronto
Hospital for Sick Children
Status: Active
Contact: Site Public Contact
Phone: 416-813-7654ext2027 Email: jason.mcguire@sickkids.ca

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 514-345-4931
The Montreal Children's Hospital of the MUHC
Status: Temporarily closed to accrual
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Quebec
Centre Hospitalier Universitaire de Quebec
Status: Temporarily closed to accrual
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Australia

Hunter Regional Mail Centre
John Hunter Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
North Adelaide
Women's and Children's Hospital-Adelaide
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Parkville
Royal Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Perth
Perth Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Randwick
Sydney Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
South Brisbane
Lady Cilento Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Westmead
The Children's Hospital at Westmead
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

New Zealand

Christchurch
Christchurch Hospital
Status: Active
Contact: Site Public Contact
Phone: 03 364 0640
Grafton
Starship Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Saudi Arabia

Riyadh
King Faisal Specialist Hospital and Research Centre
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 011-966-1-464-7272 ext 38005

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To eliminate exposure to conventional chemotherapy (including anthracyclines), for patients with standard risk acute promyelocytic leukemia (APL), through use of arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) (tretinoin) based therapy while achieving an event free survival (EFS) that is not inferior compared to historical controls.

II. To significantly reduce exposure to conventional chemotherapy, and in particular, anthracycline exposure, for patients with high risk APL, through use of ATO and ATRA based therapy while achieving an event free survival that is not inferior compared to historical controls.

SECONDARY OBJECTIVES:

I. To analyze the clinical impact of FMS-like tyrosine kinase 3 (FLT3) mutations in pediatric APL.

II. To correlate clinical outcomes with the kinetics of reduction in promyelocytic leukemia (PML)/retinoic acid receptor alpha (RARalpha) transcript level by quantitative real-time (RT)-polymerase chain reaction (PCR) (RQ-PCR) in bone marrow and peripheral blood samples from diagnosis to time points during therapy.

III. To monitor incidence of coagulopathy complications, utilizing standardized conventional supportive care, and correlate with a battery of coagulation testing.

IV. To evaluate the neurocognitive outcomes of patients treated on this protocol using patient-completed, performance-based measures of neuropsychological functioning and parent questionnaire report.

OUTLINE:

INDUCTION THERAPY: Patients with standard and high risk APL receive tretinoin orally (PO) twice daily (BID) and arsenic trioxide intravenously (IV) over 2-4 hours on days 1-28. High risk APL patients also receive dexamethasone PO or IV BID on days 1-14 and idarubicin IV over 15 minutes on days 1, 3, 5, and 7. Patients achieving hematologic complete remission (hCR)/hematologic complete remission with incomplete blood count recovery (hCRi) may go on to consolidation therapy. Patients who do not achieve hCR/hCRi may continue treatment with tretinoin and arsenic trioxide for up to 70 days.

CONSOLIDATION THERAPY: Patients receive tretinoin PO BID on days 1-14 and 29-42 and arsenic trioxide IV over 2-4 hours on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 56 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive tretinoin PO BID on days 1-14 and arsenic trioxide IV over 2-4 hours on days 1-5, 8-12, 15-19, and 22-26.

MINIMAL RESIDUAL DISEASE (MRD) CONSOLIDATION THERAPY: Patients who have APL in the bone marrow after 2 courses of consolidation therapy receive MRD consolidation therapy prior to continuing onto consolidation course 3. Patients receive cytarabine IV over 1-3 hours every 12 hours on days 1-4; mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6; and tretinoin PO BID on days 1-14. If there are no APL cells in the bone marrow after completion of MRD consolidation therapy, patients continue on to consolidation course 3.

After completion of study treatment, patients are followed up monthly for 12 months, every 3 months for 36 months, every 6 months for 48 months, and then annually for 2 years.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
Matthew A. Kutny

Trial IDs

Primary ID AAML1331
Secondary IDs NCI-2014-02266, PAAML1331_A01PAMDREVW0
Clinicaltrials.gov ID NCT02339740