Clinical trial · Interventional
Thalidomide With or Without Fludarabine in Treating Patients With Hematologic Cancer
Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine
- 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)
This randomized phase II trial is studying thalidomide and fludarabine to see how well they work compared to thalidomide alone in treating patients with hematologic cancer that has not responded to previous treatment with fludarabine. Thalidomide may stop the growth of hematologic cancer by stopping blood flow to the cancer. Combining thalidomide with fludarabine may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drug. It is not yet known whether thalidomide is more effective with or without fludarabine for hematologic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (thalidomide)
- description
- Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: thalidomide
- type
- EXPERIMENTAL
- label
- Arm II (thalidomide, fludarabine phosphate)
- description
- Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days 1-5. Treatment with fludarabine repeats every 28 days for 6 courses. Once fludarabine is completed, patients continue to receive thalidomide alone as in arm I.
- interventionNames
- Drug: fludarabine phosphate
- Drug: thalidomide
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosis of one of the following:
* Confirmed chronic lymphocytic leukemia (CLL), meeting the following criteria:
* Peripheral blood lymphocytosis greater than 5,000/mm\^3
* Co-expression of the CD5, CD19, CD20, and CD23 surface antigens
* Clonal kappa and lambda light chain expression
* Dim surface immunoglobulin expression
* Small lymphocytic lymphoma
* Relapsed or refractory disease
* Must have received at least 1 prior regimen containing fludarabine
* Meets one of the following criteria:
* Recurrence of lymphocytosis greater than 5,000/mm\^3 or an increase in lymph node volume greater than 50% after achieving complete (CR) or partial response (PR)
* Never achieved a CR or PR after receiving at least 2 courses of fludarabine IV for 5 days at a dose of 25 mg/m\^2/day
* No other lymphoproliferative diseases or diseases due to transformation of CLL (e.g., prolymphocytic leukemia or Richter's syndrome)
* No known CNS disease
* Performance status - Karnofsky 60-100%
* At least 12 weeks
* See Disease Characteristics
* Bilirubin \< 2.0 times upper limit of normal (ULN)\*
* SGOT \< 2.5 times ULN\*
* Creatinine \< 1.5 times ULN
* No history of cardiac arrhythmia
* No myocardial infarction within the past 6 months
* 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 pre-existing neurotoxicity grade 3 or greater
* No other medical condition that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Female patients must use 2 effective methods (at least 1 highly active method) of contraception 4 weeks before, during, and for 4 weeks after study participation and male patients must use effective barrier contraception during and for 4 weeks after study participation
* At least 4 weeks since prior biologic therapy and recovered
* No concurrent growth factors (epoetin alfa, filgrastim \[G-CSF\], or sargramostim \[GM-CSF\])
* See Disease Characteristics
* No more than 3 prior chemotherapy regimens
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No other concurrent chemotherapy
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
* Recovered from any prior investigational agents
* No other concurrent investigational agentsReferences
Publications (0)
Data not yet available