Status:
UNKNOWN
Risk-Adjusted Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia
Lead Sponsor:
University Hospital, Motol
Conditions:
Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief Summary
RATIONALE: 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 c...
Detailed Description
OBJECTIVES: * To test in a randomized way the type and intensity of reintensification therapy for pediatric patients with acute lymphoblastic leukemia in each risk group: standard-risk (SR), intermed...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Cytologically proven acute lymphoblastic leukemia (ALL)
- No relapse of a previously unrecognized ALL
- Patients must meet one of the following risk criteria:
- Standard-risk (SR) group meeting all of the following criteria:
- Blasts \< 1,000/μL in peripheral blood (PB) on day 8
- Aged 1 to \< 6 years
- Initial WBC \< 20,000/μL
- M1 (5%) or M2 (≥ 5% to \< 25%) blasts in bone marrow on day 15
- M1 marrow on day 33
- Intermediate-risk (IR) group meeting all of the following criteria:
- Aged \< 1 or ≥ 6 years and/or WBC ≥ 20,000/μL
- Blasts \< 1,000/μL in PB on day 8
- M1 or M2 marrow on day 15
- M3 (≥ 25%) marrow on day 15 OR meets SR criteria but M3 marrow on day 15 and M1 marrow on day 33
- High-risk (HR) group meeting ≥ 1 of the following criteria:
- Meets IR criteria and M3 marrow on day 15 (not SR and M3 on day 15)
- Blasts ≥ 1,000/μL in PB on day 8
- M2 or M3 marrow on day 33
- Translocation t(9;22) \[BCR/ABL+\] (Philadelphia chromosome-positive) or t(4;11) \[MLL/AF4+\]
- No secondary ALL
- PATIENT CHARACTERISTICS:
- No Down syndrome
- No other major disease that prohibits study treatment (e.g., severe congenital heart disease)
- Not requiring significant therapy modification owing to study therapy-associated complications
- No complications due to other interventions
- No one with missing data that are needed for the differential diagnosis, or for selection of the proper therapy arm
- PRIOR CONCURRENT THERAPY:
- No steroids or cytostatic drugs within four weeks prior to start of study therapy
Exclusion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT00764907
Start Date
November 1 2002
Last Update
July 8 2009
Active Locations (1)
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1
University Hospital Motol
Prague, Czechia, 150 06