Status:
WITHDRAWN
Low-Dose Cytarabine in Treating Infants With Down Syndrome and Transient Myeloproliferative Disorder
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. Giving low-doses ...
Detailed Description
OBJECTIVES: Primary * Determine whether very low-dose cytarabine can improve event-free survival (EFS) rates in infants with high-risk transient myeloproliferative disorder (TMD), using high-risk TM...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of transient myeloproliferative disorder (TMD)
- Diagnosis of Down syndrome or Down syndrome mosaicism (confirmed by karyotype analysis within the past 3 weeks) AND 1 of the following:
- Nonerythroid and nonlymphoid blasts (any amount) in the peripheral blood with verification of a second sample
- Trisomy 21-positive leukemic blasts documented by biopsy of any organ (including \> 5% nonerythroid/nonlymphoid blasts documented by bone marrow aspirate or biopsy)
- Immunophenotype characterization required
- High-, intermediate-, or low-risk TMD, as defined by the following:
- High-risk TMD, meeting 1 of the following criteria:
- Life-threatening cardio-respiratory compromise due to complications of TMD (e.g., organomegaly or effusions)
- Life-threatening cardio-respiratory compromise is defined as cardiovascular grade 4 edema, grade 4 pericardial effusions, or grade 4 pleural effusions
- Hyperleukocytosis, defined as a WBC \> 100,000/mm³
- Any degree of hepatomegaly (palpable on physical exam) combined with life-threatening hepatic dysfunction
- Life-threatening hepatic dysfunction is defined as grade 4 disseminated intravascular coagulation, grade 4 ascites, grade 4 bilirubin (\> 10.0 times upper limit of normal \[ULN\]), or grade 4 AST or ALT (\> 20.0 times ULN)
- Intermediate-risk TMD, meeting all of the following criteria:
- Hepatomegaly (palpable on physical exam) combined with non life-threatening hepatic dysfunction (i.e., grade 1-3 hepatic dysfunction \[AST or ALT ≤ 2.5 times ULN\] and/or a total or direct bilirubin ≤ 1.5 times ULN)
- No evidence of life-threatening cardiovascular, respiratory, or hepatic compromise due to complications of TMD
- Low-risk TMD, meeting all of the following criteria:
- No palpable hepatomegaly on physical exam OR hepatomegaly is present without hepatic dysfunction (i.e., grade 0 hepatic dysfunction)
- No evidence of life-threatening cardiovascular, respiratory, or hepatic compromise due to complications of TMD
- PATIENT CHARACTERISTICS:
- See Disease Characteristics
- No biliary atresia by hepatic ultrasound for patients with bilirubin 3.0-10.0 times ULN
- PRIOR CONCURRENT THERAPY:
- No prior antileukemic therapy (except for leukapheresis or exchange transfusion)
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00411281
Start Date
March 1 2006
End Date
November 1 2007
Last Update
September 30 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.