Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

Completed · Phase 3

Conditions studied: Childhood Acute Promyelocytic Leukemia With PML-RARA, Myeloid Neoplasm

In brief

This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Key facts

Study ID: NCT00866918
Run by: Children's Oncology Group
People needed: 106
Starts: 2009-03-09
Expected to finish: 2022-09-30
Last updated by the study team: 2022-10-25

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must be newly diagnosed with a clinical diagnosis of acute promyelocytic leukemia initially by morphology (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; APL is considered a hematological emergency and treatment should be initiated as quickly as possible without waiting for molecular or cytogenetic/fluorescence in situ hybridization (FISH) confirmation; for patients who are unable to begin receiving ATRA in a timely manner following a presumed diagnosis of APL, consideration should be given to initiating ATRA and proceeding with treatment outside of the AAML0631 protocol; if the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate PML-RARA and/or RARA-PML transcripts by RQ-PCR to be eligible; patients without evidence of APL by bone marrow or peripheral blood morphology but with isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis) are eligible provided that the t(15;17) translocation is documented on either marrow or tumor tissue by cytogenetics, FISH, or PCR prior to study enrollment; in this situation, touch preps from the tumor site can be evaluated by FISH with PML-RARA probes; NOTE: A lumbar puncture is not required to be enrolled on study; if the diagnosis of APL is known or suspected, extreme caution must be exercised in performing a lumbar puncture during active coagulopathy; in addition a computed tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out the possibility of an associated chloroma if central nervous system (CNS) disease is suspected or proven; if CNS disease is documented, patients are still eligible
No minimal performance status criteria
The patient must not have received systemic definitive treatment for APL or other suspected leukemia, including cytotoxic chemotherapy, retinoids, or arsenic; prior therapy with corticosteroids, hydroxyurea, or leukopheresis will not exclude the patient; if a patient received intrathecal cytarabine prior to the diagnosis of APL being known, the patient will still be eligible as long as they meet all other eligibility requirements

You may not qualify if…

Pregnant women or nursing mothers are excluded; treatment under this protocol would expose an unborn child to significant risks; patients should not be pregnant or plan to become pregnant while on treatment; women and men of reproductive potential should agree to use an effective means of birth control; there is an extremely high risk of fetal malformation if pregnancy occurs while on ATRA in any amount even for short periods
Patients with a pre-existing prolonged QT Syndrome will not be eligible for this protocol due to the use of arsenic trioxide which can prolong the QT interval

Where it is running

University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
Phoenix Childrens Hospital — Phoenix, Arizona, United States
Arkansas Children's Hospital — Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center — Downey, California, United States
Loma Linda University Medical Center — Loma Linda, California, United States
Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
Children's Hospital Los Angeles — Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
Valley Children's Hospital — Madera, California, United States
UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
Children's Hospital of Orange County — Orange, California, United States
Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
Rady Children's Hospital - San Diego — San Diego, California, United States
UCSF Medical Center-Mount Zion — San Francisco, California, United States
UCSF Medical Center-Parnassus — San Francisco, California, United States
Harbor-University of California at Los Angeles Medical Center — Torrance, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
University of Connecticut — Farmington, Connecticut, United States
Connecticut Children's Medical Center — Hartford, Connecticut, United States
Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Lee Memorial Health System — Fort Myers, Florida, United States
Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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