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

Plain-language summary

This study looks at using several chemotherapy drugs together in young patients who have Down syndrome along with acute myeloid leukemia or myelodysplastic syndromes. Newly diagnosed young patients with Down syndrome were able to take part. Sponsored by the Children's Oncology Group, the study was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Children's Oncology Group

Intervention

asparaginase, daunorubicin hydrochloride, cytarabine, thioguanine, etoposide, laboratory biomarker analysis

Start date

3/1/2007

Estimated completion

12/31/2021

Countries

United States, Australia, Canada, Puerto Rico

Related genes

Locations

• Phoenix, United States
• Downey, United States
• Long Beach, United States
• Los Angeles, United States
• Madera, United States
• Oakland, United States
• Oakland, United States
• Orange, United States
• Palo Alto, United States
• San Diego, United States
• San Francisco, United States
• Aurora, United States
• Wilmington, United States
• Washington D.C., United States
• Washington D.C., United States
• Fort Lauderdale, United States
• Hollywood, United States
• Jacksonville, United States
• Orlando, United States
• St. Petersburg, United States
• Atlanta, United States
• Honolulu, United States
• Boise, United States
• Chicago, United States
• Maywood, United States
• Park Ridge, United States
• Peoria, United States
• Springfield, United States
• Indianapolis, United States
• Indianapolis, United States
• Indianapolis, United States
• Louisville, United States
• New Orleans, United States
• Bangor, United States
• Baltimore, United States
• Baltimore, United States
• Bethesda, United States
• Ann Arbor, United States
• Detroit, United States
• Detroit, United States

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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