Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Recruiting
3 years or below
All
Phase N/A
1 Location

Brief description of study

The purpose of this study is to treat for AML in Down Syndrome patients.

Detailed description of study

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: acute myeloid leukemia,Down Syndrome
  • Age: 3 years or below
  • Gender: All

Inclusion Criteria

Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization [FISH])

Patient has one of the following:

- Patients has previously untreated de novo AML and meets the criteria for AML with >= 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification

-Patients has cytopenias and/or bone marrow blasts but does not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of < 20% marrow blasts and meets the criteria for a diagnosis of myelodysplastic syndrome (MDS)

- Patients has a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention)

- Patients who have an increasing blast count (>= 5%) in serial bone marrow aspirates performed at least 4 weeks apart

Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD

There are no minimal organ function requirements for enrollment on this study - Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria

Exclusion Criteria

Patients with promyelocytic leukemia

 Prior therapy

Patients =< 30 days from the last dose of cytarabine used for treatment of TMD

Updated on 04 Aug 2024. Study ID: 1512126225 (PHO-COG-FALLON-AAML1531)

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