Status:
TERMINATED
Combination Chemotherapy With or Without G-CSF in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Lead Sponsor:
German CLL Study Group
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine, mitoxantrone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping th...
Detailed Description
OBJECTIVES: Primary * Compare the rate of remission, severe infections, and side effects in patients with relapsed advanced chronic lymphocytic leukemia treated with fludarabine, mitoxantrone hydroc...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed relapsed and advanced chronic lymphocytic leukemia (CLL)
- Binet stage B or C disease with rapid disease progression, enlarged lymph nodes and organs, or severe B-symptoms
- No prior non-response to fludarabine combination therapy
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Life expectancy \> 6 months
- No severe organ dysfunction
- No other prior or concurrent neoplasm, autoimmune hemolytic anemia, or thrombocytopenia
- PRIOR CONCURRENT THERAPY:
- No more than three previous treatment regimens for CLL (fludarabine allowed)
Exclusion
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00416910
Start Date
July 1 1999
End Date
September 1 2007
Last Update
September 26 2016
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