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Status:

COMPLETED

Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Childhood Acute Basophilic Leukemia

Childhood Acute Eosinophilic Leukemia

Eligibility:

All Genders

Up to 4 years

Phase:

PHASE3

Brief Summary

This phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemothera...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the event-free survival (EFS) and overall survival rates in pediatric patients with Down syndrome (DS) and acute myeloid leukemia AML or myelodysplastic syndromes MDS...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Diagnosis DS or DS mosaicism by karyotype or chromosomal analysis
  • Diagnosis of myelodysplastic syndromes (MDS) with \< 30% blasts or acute myeloid leukemia (AML)
  • Newly diagnosed disease
  • Patients with a history of transient myeloproliferative disorder (TMD) are eligible provided the patient is diagnosed with AML or MDS at \> 90 days of age AND meets either of the following criteria:
  • At least 30% blasts in the bone marrow regardless of time since resolution of TMD
  • More than 8 weeks since resolution of TMD with ≥ 5% blasts in the bone marrow
  • Immunophenotype required for study entry
  • No promyelocytic leukemia
  • Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT \< 2.5 times ULN
  • Creatinine adjusted according to age as follows:
  • No greater than 0.4 mg/dL (≤ 5 months)
  • No greater than 0.5 mg/dL (6 months -11 months)
  • No greater than 0.6 mg/dL (1 year-23 months)
  • No greater than 0.8 mg/dL (2 years-5 years)
  • No greater than 1.0 mg/dL (6 years-9 years)
  • No greater than 1.2 mg/dL (10 years-12 years)
  • No greater than 1.4 mg/dL (13 years and over \[female\])
  • No greater than 1.5 mg/dL (13 years to 15 years \[male\])
  • No greater than 1.7 mg/dL (16 years and over \[male\])
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
  • No evidence of dyspnea at rest
  • No exercise intolerance
  • Pulse oximetry \> 94%
  • No prior chemotherapy, radiotherapy, or any antileukemic therapy
  • Intrathecal cytarabine therapy given at diagnosis allowed
  • Prior therapy for TMD allowed

Exclusion

    Key Trial Info

    Start Date :

    March 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 31 2021

    Estimated Enrollment :

    205 Patients enrolled

    Trial Details

    Trial ID

    NCT00369317

    Start Date

    March 1 2007

    End Date

    December 31 2021

    Last Update

    January 28 2022

    Active Locations (97)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 25 (97 locations)

    1

    Phoenix Childrens Hospital

    Phoenix, Arizona, United States, 85016

    2

    Southern California Permanente Medical Group

    Downey, California, United States, 90242

    3

    Miller Children's Hospital

    Long Beach, California, United States, 90806

    4

    Children's Hospital Los Angeles

    Los Angeles, California, United States, 90027