Clinical trial · Interventional
Dose Escalation Study of Revlimid With Fludarabine-Rituximab for CLL/SLL
A Phase I Dose Escalation Study of Lenalidomide (Revlimid) in Combination With Fludarabine-Rituximab (Rituxan) for Previously Untreated CLL/SLL
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of efficacy and tolerability
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety of lenalidomide (revlimid) in combination with fludarabine and rituximab and to determine the highest dose of lenalidomide that can safely be given in that combination. Lenalidomide is a drug that alters the immune system and may also interfere with the the development of tiny blood vessels that help support tumor growth. Lenalidomide is approved by the FDA for the treatment of two different blood cancers called myelodysplastic syndrome and multiple myeloma. Lenalidomide has also been studied in subjects with relapsed CLL. In this research study we are adding lenalidomide to a well-established initial therapy for CLL/SLL.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine | Drug | Fludarabine | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide, fludarabine and rituximab
- description
- Lenalidomide-Dose level will depend upon time the participant enrolls on the study: Given orally once a day for 3 weeks followed by a one week rest period fludarabine- Dose level will vary depending upon when participant enters the trial: Given intravenously for 3-5 days Rituximab- Given intravenously on Day 1 of each 28 day cycle
- interventionNames
- Drug: Lenalidomide
- Drug: Fludarabine
- Drug: Rituximab
Primary outcomes (1)
- measure
- To evaluate the safety of lenalidomide in combination with fludarabine-rituximab (FR) and to determine the maximum tolerated dose in subjects with previously untreated CLL/SLL.
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- To determine the objective response rate and progression-free survival following lenalidomide/FR in this patient population
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Diagnosed with B-CLL/SLL based on the standard histologic and immunophenotypic criteria described in the WHO classification * No prior systemic therapy for CLL/SLL, including chemotherapy or antibody therapy * Currently needs therapy based on 1996 NCI-WG criteria * Measurable disease * ECOG Performance Status of 0-2 * Laboratory test results within parameters outlined in protocol * Able to take aspirin daily as prophylactic anticoagulation Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document * Pregnant or breast-feeding females * Any condition, including the presence of abnormal laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study * Use of any other experimental drug or therapy within 28 days of baseline * Known hypersensitivity to thalidomide * Development of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs * Prior use of lenalidomide * Concurrent use of other anti-cancer agents or treatments * Known positive for HIV * Chronic active Hep B patients not on prophylactic lamivudine * Diagnosis of Mantle Cell Lymphoma
References
Publications (0)
Data not yet available