Clinical trial · Interventional
Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Aggressive B-Cell Lymphoma
Rituximab, Bendamustine and Lenalidomide in Patients With Aggressive B-cell Lymphoma Not Eligible for High Dose Chemotherapy or Anthracycline-Based Therapy. A Phase I/II Trial.
NCT00987493CI-TRIAL-00038641completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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: Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Giving rituximab together with bendamustine hydrochloride and lenalidomide may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving rituximab together with bendamustine hydrochloride and lenalidomide in treating patients with aggressive B-cell lymphoma.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bendamustine hydrochloride | Drug | Bendamustine | ALIAS |
| lenalidomide | Drug | Lenalidomide | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with rituximab, bendamustine and lenalidomide
- interventionNames
- Biological: rituximab
- Drug: bendamustine hydrochloride
- Drug: lenalidomide
Primary outcomes (3)
- measure
- Dose-limiting toxicity (phase I)
- timeFrame
- at 4 weeks.
- measure
- Maximum-tolerated dose (phase I)
- timeFrame
- at the end of phase I (31 August 2011)
- measure
- Objective response (complete and partial response) (phase II)
- timeFrame
- phase II (3 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed aggressive B-cell non-Hodgkin lymphoma, including any of the following: * Diffuse large B-cell lymphoma (variants, subgroups, and subtypes according to WHO criteria) * Transformed follicular lymphoma * Follicular lymphoma grade 3B * Meets 1 of the following criteria: * Not eligible for anthracycline-based first-line chemotherapy (e.g., R-CHOP) * Refractory disease after at least 2 courses of anthracycline-based immune-chemotherapy (e.g., R-CHOP) and patient is not eligible for intensive salvage regimens including HDT with ASCT * Relapsed disease after at least 1 treatment with curative intention and patient is not eligible for intensive salvage regimens including HDT with ASCT * Relapsed disease after HDT with ASCT * Measurable disease defined as ≥ 1 lesion ≥ 2 cm in greatest transverse diameter on cross-sectional imaging * Must complete pre-treatment cancer-specific geriatric assessment and/or quality-of-life questionnaire (phase II only) * No known CNS involvement * Diagnostic procedures required only in case of specific symptoms PATIENT CHARACTERISTICS: * WHO performance status (PS) 0-2 * WHO PS 3 allowed in case of lymphoma-related impaired general condition (phase II only) * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT ≤ 2 times ULN * Alkaline phosphatase 2 times ULN * Creatinine clearance \> 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after completion of study therapy * EF ≥ 40% by echocardiography or MUGA scan * Negative HIV test * Able to comply with and geographic proximity to allow proper staging and study follow-up * Agree to follow the special prescribing requirements for lenalidomide * No other malignancy within the past 3 years except adequately treated cervical carcinoma in situ or localized nonmelanoma skin cancer * No unstable cardiovascular disease * No psychiatric disorder precluding understanding of information on trial-related topics, giving informed consent, or interfering with compliance for oral drug intake * No serious underlying medical condition that, in the judgement of the investigator, could impair the ability of the patient to participate in the trial including, but not limited to, any of the following conditions: * Acute or ongoing infection * Uncontrolled diabetes mellitus * Active autoimmune disease * No known hypersensitivity to any component of the trial drugs PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No experimental drugs within the past 30 days * No concurrent drugs contraindicated with the trial drugs according to the Swissmedic-approved product information * No other concurrent anticancer or investigational drugs or radiotherapy
References
Publications (2)
- RESULTHitz F, Zucca E, Pabst T, Fischer N, Cairoli A, Samaras P, Caspar CB, Mach N, Krasniqi F, Schmidt A, Rothermundt C, Enoiu M, Eckhardt K, Berardi Vilei S, Rondeau S, Mey U. Rituximab, bendamustine and lenalidomide in patients with aggressive B-cell lymphoma not eligible for anthracycline-based therapy or intensive salvage chemotherapy - SAKK 38/08. Br J Haematol. 2016 Jul;174(2):255-63. doi: 10.1111/bjh.14049. Epub 2016 Mar 28. PMID 27018242
- RESULTHitz F, Fischer N, Pabst T, Caspar C, Berthod G, Eckhardt K, Berardi Vilei S, Zucca E, Mey U; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland. Rituximab, bendamustine, and lenalidomide in patients with aggressive B cell lymphoma not eligible for high-dose chemotherapy or anthracycline-based therapy: phase I results of the SAKK 38/08 trial. Ann Hematol. 2013 Aug;92(8):1033-40. doi: 10.1007/s00277-013-1751-z. Epub 2013 Apr 17. PMID 23592273