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Arsenic compound

Arm I (standard risk, combination chemotherapy) for Acute Promyelocytic Leukemia

Phase 3
Waitlist Available
Led By John Gregory, MD
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 years from study entry
Awards & highlights

Study Summary

This trial is testing a new combination chemotherapy treatment for children with a particular type of leukemia.

Eligible Conditions
  • Acute Promyelocytic Leukemia
  • Myeloid Neoplasm

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 years from study entry
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 years from study entry for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free Survival (EFS)
Secondary outcome measures
Hematologic Remission Rate
Hematologic, Molecular, and Cytogenetic Remission Rate
Overall Survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (high risk, combination chemotherapy)Experimental Treatment8 Interventions
See Detailed Description.
Group II: Arm I (standard risk, combination chemotherapy)Experimental Treatment8 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arsenic Trioxide
2011
Completed Phase 3
~240
Cytarabine
2016
Completed Phase 3
~3310
Idarubicin
2014
Completed Phase 4
~4330
Mercaptopurine
2012
Completed Phase 4
~12330
Methotrexate
2013
Completed Phase 4
~3800
Mitoxantrone Hydrochloride
2016
Completed Phase 3
~650
Tretinoin
2013
Completed Phase 4
~2040

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,294 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,615 Previous Clinical Trials
40,918,514 Total Patients Enrolled
John Gregory, MDPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Mar 2025