Trial Search Results

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

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 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Drug: asparaginase
  • Drug: daunorubicin hydrochloride
  • Drug: cytarabine
  • Drug: thioguanine
  • Drug: etoposide
  • Other: laboratory biomarker analysis


Phase 3


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

   - 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

Ages Eligible for Study

N/A - 4 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
Not Recruiting