Status:
COMPLETED
Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia (CLL) That Did Not Respond to Fludarabine, CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)
Lead Sponsor:
German CLL Study Group
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Monoclonal antibodies, such as rituximab...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy, in terms of the rate and quality of remission, of chemotherapy comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and ritu...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed diagnosis of previously treated chronic lymphocytic leukemia (CLL) meeting the following criteria:
- Binet stage B (Rai stages I and II) or Binet stage C (Rai stages III and IV) disease
- Rapid disease progression, symptomatic enlarged lymph nodes, or severe B-cell symptoms
- CLL with autoimmune hemolytic anemia allowed
- Richter transformation allowed
- PATIENT CHARACTERISTICS:
- Life expectancy \> 3 months
- ECOG performance status 0-3
- No severe organ dysfunction
- No other prior or concurrent neoplasms
- PRIOR CONCURRENT THERAPY:
- No more than 4 prior chemotherapy regimens
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00309881
Start Date
April 1 2003
End Date
March 1 2011
Last Update
October 3 2016
Active Locations (18)
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1
Kreiskrankenhaus
Bad Hersfeld, Germany, 36251
2
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, Germany, 28239
3
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany, D-50924
4
Universitaetsklinikum Essen
Essen, Germany, D-45122