Clinical trial · Interventional
Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study
- 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)
Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify or regulate the functioning of the immune system. It is an FDA approved drug for people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL), but it does appear effective in CLL when used alone, and is being studied for use in combination with chemotherapy in this and other lymphomas and leukemias. In this research study we are hoping to learn more about the effects of lenalidomide on CLL when given in combination with bendamustine and rituximab, which is a highly effective regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest dose of lenalidomide that can be given safely, without causing any serious or unmanageable side effects.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Chronic Lymphocytic Leukemia | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL
- timeFrame
- 2 year
- measure
- Clinical efficacy
- timeFrame
- 2 years
- description
- response rate, progression-free and overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with B-cell CLL or SLL (chronic lymphocytic leukemia or small lymphocytic leukemia) * Life expectancy \> 3 months * Organ and marrow function with protocol parameters * Able to take aspirin daily Exclusion Criteria: * Age \>80 years * Prior systemic therapy for CLL/SLL including chemotherapy or antibody therapy * Pregnant or breast-feeding * Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent * Known hypersensitivity to thalidomide or lenalidomide * Prior use of lenalidomide * Concurrent use of other anti-cancer agents or treatments * HIV positive * Prior history of another malignancy unless disease free for at least 2 years * Uncontrolled intercurrent illness
References
Publications (0)
Data not yet available