Status:
COMPLETED
Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as thalidomide use differen...
Detailed Description
OBJECTIVES: * Determine the safety and efficacy of fludarabine and thalidomide in patients with newly diagnosed B-cell chronic lymphocytic leukemia. * Determine the overall response rate (complete an...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) based on the following criteria:
- Peripheral blood lymphocytosis \> 5,000/mm\^3
- Co-expression of CD5, CD19 or CD20, and CD23 surface antigens
- Clonal kappa or lambda light chain expression
- No recurrent or refractory CLL
- No other lymphoproliferative diseases or diseases due to transformation of CLL, such as prolymphocytic leukemia or Richter's syndrome
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Karnofsky 60-100%
- Life expectancy
- At least 12 weeks
- Hematopoietic
- See Disease Characteristics
- Hepatic
- Bilirubin \< 1.5 mg/dL
- AST \< 2.5 times upper limit of normal
- Renal
- Creatinine ≤ 1.5 mg/dL
- Cardiovascular
- No cardiac arrhythmia within the past 6 months
- No myocardial infarction within the past 6 months
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use at least 1 highly active and 1 additional method of contraception for 4 weeks before, during, and for at least 4 weeks after study treatment
- Patients must have sufficient mental capacity to understand the study explanation and provide informed consent
- No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- No active serious infection uncontrolled by antibiotics
- No medical condition or reason that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- No prior therapy for CLL
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00096018
Start Date
May 1 2002
End Date
May 1 2012
Last Update
October 24 2013
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001