Status:
COMPLETED
Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Leukemia
Eligibility:
All Genders
1-18 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. It is not yet known which combination ch...
Detailed Description
OBJECTIVES: Primary * Evaluate the progression-free survival (defined as the time from study entry to the first occurrence of progression, relapse, death while in complete clinical remission, or sec...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:
- In first relapse after treatment
- Has not yet received chemotherapy or radiotherapy for the first relapse
- Primary refractory disease
- No mature B-cell ALL
- Meets criteria for one of the following risk groups:
- Standard-risk disease: non-T-cell or T-cell ALL with late isolated extramedullary relapse
- Intermediate-risk disease: non-T-cell ALL with early isolated extramedullary relapse or combined marrow and extramedullary relapse; non-T-cell ALL with late combined marrow and extramedullary relapse or isolated marrow relapse; or T-cell ALL with early isolated extramedullary relapse
- High-risk disease: non-T-cell ALL with very early isolated extramedullary relapse, combined marrow and extramedullary relapse, or isolated marrow relapse; non-T-cell ALL with early isolated marrow relapse; T-cell ALL with very early isolated extramedullary relapse, combined marrow and extramedullary relapse, or isolated marrow relapse; T-cell ALL with early combined marrow and extramedullary relapse or isolated marrow relapse; or T-cell ALL with late combined marrow and extramedullary relapse or isolated marrow relapse
- PATIENT CHARACTERISTICS:
- Not specified
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior bone marrow transplant
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT00967057
Start Date
October 1 2002
End Date
December 1 2011
Last Update
August 12 2013
Active Locations (6)
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1
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
2
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
3
Bristol Royal Hospital for Children
Bristol, England, United Kingdom, BS2 8BJ
4
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH