Phase 2
N=43
Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00096018 ↗Enrolled (actual)
43
Serious AEs
55.3%
Results posted
Mar 2013
Primary outcome: Primary: Overall Responders (Complete and Partial Response) — 8; 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fludarabine phosphate (Drug); thalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Responders (Complete and Partial Response) |
8; 18 | — |
| PRIMARY Duration of Response |
43.3; 30.0 | — |
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 different ways to stimulate the immune system and stop cancer cells from growing. Combining fludarabine with thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of thalidomide when given together with fludarabine and to see how well they work in treating patients with newly diagnosed B-cell chronic lymphocytic leukemia.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00096018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.