Status:
COMPLETED
Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With CLL
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cance...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy and tolerability of cladribine and rituximab as remission induction therapy in patients with chronic lymphocytic leukemia. * Determine the complete remis...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of B-cell chronic lymphocytic leukemia (CLL)
- CD5 positive and CD23 positive
- Binet stage B, C, or progressive A
- Newly diagnosed disease OR no more than 1 prior alkylating agent regimen (e.g., chlorambucil or cyclophosphamide with or without prednisone)
- PATIENT CHARACTERISTICS:
- Age
- 18 to 65
- Performance status
- WHO 0-2
- Life expectancy
- Not specified
- Hematopoietic
- No autoimmune hemolytic anemia
- No immune thrombocytopenia
- Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN\*
- AST and ALT no greater than 2.5 times ULN\* NOTE: \*Unless clearly related to CLL liver involvement
- Renal
- Creatinine clearance greater than 50 mL/min
- Cardiovascular
- Ejection fraction at least 50%
- No severe heart failure
- No unstable angina pectoris
- No significant arrhythmia requiring chronic treatment
- No myocardial infarction within the past 3 months
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after study participation
- HIV negative
- No active infection
- No positive Coombs' test
- No history of significant neurologic or psychiatric disorders, including psychotic disorders or dementia
- No seizure disorder
- No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
- No prior allergic reaction or hypersensitivity to study drugs or attributed to compounds of similar chemical or biological composition to study drugs or other study agents
- No uncontrolled diabetes mellitus
- No gastric ulcers
- No active autoimmune disease
- No alcohol or drug abuse
- No other concurrent serious underlying medical condition that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- No prior purine analogs (e.g., cladribine or fludarabine)
- Endocrine therapy
- Not specified
- Radiotherapy
- No concurrent radiotherapy
- Surgery
- Not specified
- Other
- More than 30 days since prior clinical trial participation
- No other concurrent experimental drugs
Exclusion
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00072007
Start Date
June 1 2002
End Date
October 1 2010
Last Update
May 15 2012
Active Locations (11)
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1
Kantonspital Aarau
Aarau, Switzerland, 5001
2
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
3
Inselspital Bern
Bern, Switzerland, CH-3010
4
Spitaeler Chur AG
Chur, Switzerland, CH-7000