Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelo… (NCT00003593) | Clinical Trial Compass
CompletedPhase 3
Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome
United States254 participantsStarted 1999-06
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Cytogenetically proven Down Syndrome (constitutional trisomy 21) with transient myeloproliferative disorder (TMD), myelodysplastic syndromes (MDS), or acute myelogenous leukemia (AML)
* Must be confirmed by bone marrow aspirate, cerebrospinal fluid exam, or blood test
* Trisomy 21 mosaicism allowed
* Group I:
* Diagnosis of TMD in patients no older than 90 days at initial presentation
* Must have nonerythroid blasts (any amount) in the peripheral blood and one of the following:
* Verification with a second sample
* More than 5% bone marrow blasts
* Hepatomegaly and/or splenomegaly
* Lymphadenopathy
* Cardiac or pleural effusions OR
* Histologically or cytologically proven TMD with blasts in an affected organ or in fluid (pericardial, pleural, or peritoneal)
* Bone marrow aspirate is required
* Group II (closed to accrual as of 6/24/04):
* Diagnosis of MDS or AML (except M3 subtype) in patients older than 90 days with more than 29% blasts in bone marrow (with or without history of TMD), or any of the following histologies:
* Refractory anemia (RA)
* RA with excess blasts (RAEB)
* RAEB in transformation
* RA with ringed sideroblasts (RARS)
* Primary cytopenia (later confirmed by bone marrow aspirate as due to marrow hypoplasia) defined by one or more of the following:
* Absolute neutrophil count less than 500/mm\^3
* Untransfused platelet count less than 30,000/mm\^3
* Untr…