Clinical trial · Interventional
Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL
Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide Followed by Rituximab/Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Concomitant Evaluation of Safety and Efficacy.
- 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)
The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.
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, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine | Drug | Fludarabine | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Lenalidomide Dose Escalation combined with Fludarabine/Rituximab followed by maximum tolerated lenalidomide dose/Rituximab maintenance therapy
- interventionNames
- Drug: Lenalidomide
- Drug: Fludarabine
- Biological: Rituximab
Primary outcomes (1)
- measure
- Lenalidomide Maximum Tolerated Dose
- timeFrame
- Dose escalation stage
Secondary outcomes (7)
- measure
- Safety profile of Lenalidomide/Fludarabine/Rituximab treatment
- timeFrame
- Study Duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * B-CLL (CD23+, CD5+, CD19+, CD20+) * Treatment indication according to NCI criteria * Age \>= 18 yrs * No previous treatment of CLL by chemo-, radio- or immunotherapy * Life expectancy \> 6 months * Written informed consent * Women of non-childbearing potential or women of childbearing potential and men using effective contraception Exclusion Criteria: * Active bacterial, viral or fungal infection * Positivity for HIV, Hepatitis B or C * Reduce organ functions and bone marrow dysfunction not due to CLL * Creatinine clearance below 30 ml/min * Patients with medical conditions requiring long-term use of systemic corticosteroids during study treatment * Patients with a history of severe cardiac disease * Other known co-morbidity with the potential to dominate survival * Transformation to aggressive B-cell malignancy * Known hypersensitivity to humanised monoclonal antibodies or any of the study drugs * Pregnant or breast-feeding women * Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
References
Publications (1)
- DERIVEDEgle A, Steurer M, Melchardt T, Weiss L, Gassner FJ, Zaborsky N, Geisberger R, Catakovic K, Hartmann TN, Pleyer L, Voskova D, Thaler J, Lang A, Girschikofsky M, Petzer A, Greil R. Fludarabine and rituximab with escalating doses of lenalidomide followed by lenalidomide/rituximab maintenance in previously untreated chronic lymphocytic leukaemia (CLL): the REVLIRIT CLL-5 AGMT phase I/II study. Ann Hematol. 2018 Oct;97(10):1825-1839. doi: 10.1007/s00277-018-3380-z. Epub 2018 Jun 4. PMID 29862437