Clinical trial · Interventional
Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
A Phase I/II Study of Fludarabine Plus Thalidomide as Frontline Therapy for Newly Diagnosed Patients With Chronic Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days
- interventionNames
- Drug: fludarabine phosphate
- Drug: thalidomide
Primary outcomes (2)
- measure
- Overall Responders (Complete and Partial Response)
- timeFrame
- 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years
- description
- Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.)
- measure
- Duration of Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTChanan-Khan A, Miller KC, Takeshita K, Koryzna A, Donohue K, Bernstein ZP, Mohr A, Klippenstein D, Wallace P, Zeldis JB, Berger C, Czuczman MS. Results of a phase 1 clinical trial of thalidomide in combination with fludarabine as initial therapy for patients with treatment-requiring chronic lymphocytic leukemia (CLL). Blood. 2005 Nov 15;106(10):3348-52. doi: 10.1182/blood-2005-02-0669. Epub 2005 Jul 28. PMID 16051743