Overview

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

Status:
Active, not recruiting
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
6-Mercaptopurine
Arsenic Trioxide
Cytarabine
Idarubicin
Mercaptopurine
Methotrexate
Mitoxantrone
Tretinoin
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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