AAML1531 : Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

<3Age Under 3

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia,Myelodysplasia

Trial Overview Read MoreRead more

This phase III trial is evaluating different types of response-based chemotherapy in treating newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic syndrome in younger patients with Down syndrome.
 

This trial is treating patients with Down syndrome who have been diagnosed with Acute Myeloid Leukaemia (AML) or Myelodysplastic syndrome.

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Cooperative Group

Children's Oncology Group

Other Non-Commercial Sponsor

National Cancer Institute (NCI)

Summary

Drugs used in chemotherapy 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. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects. OUTLINE: INDUCTION I: Patients receive cytarabine intrathecally (IT) on day 1 and intravenously (IV) continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine orally (PO) twice daily (BID) on days 1-4. Induction I continues for a minimum of 28 days. Patients are assigned to 1 of 2 treatment arms based on their MRD status after completion of Induction I. ARM A (STANDARD RISK): INDUCTION II: Patients receive cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine PO BID on days 1-4. Induction II continues for a minimum of 28 days. INDUCTION III: Patients receive cytarabine, daunorubicin hydrochloride, and thioguanine as in Induction II. Induction III continues for a minimum of 28 days. INTENSIFICATION I: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 60-120 minutes on days 1-3. Intensification I continues for a minimum of 28 days. INTENSIFICATION II: Patients receive cytarabine and etoposide as in Intensification I. Intensification II continues for a minimum of 28 days. ARM B (HIGH RISK): INDUCTION II: Patients receive high dose cytarabine IV over 1-3 hours BID on days 1-4 and mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6. Induction II continues for a minimum of 28 days. INTENSIFICATION I: Patients receive high dose cytarabine IV over 1-3 hours BID and etoposide IV over 60-120 minutes on days 1-5. Intensification I continues for a minimum of 28 days. INTENSIFICATION II: Patients receive high dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9. Patients also receive asparaginase or asparaginase Erwinia chrysanthemi (E. carotovora) intramuscularly (IM) or IV over 30 minutes on days 2 and 9. Intensification II continues for a minimum of 28 days. After completion of study treatment, patients are followed up at 1 month, monthly for 12 months, every 3 months for 12 months, every 6 months for 3 years, annually for 5 years, and then at relapse.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Trial Coordinator
CCC.ClinicalTrials@rch.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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