Clinical trial · Interventional
Lenalidomide, MTX, Ara-C and Rituximab in Relapsed Aggressive B-cell Lymphomas
Lenalidomide in Conjunction With Methotrexate, Leucovorin, Cytarabine and Rituximab for the Treatment of Relapsed or Refractory CD20-positive Aggressive Lymphomas: an Open-label, Multicenter Phase I/II Trial
- 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)
Multicenter prospective open-label non-randomised phase I/II study in patients with relapsed or refractory CD20-positive aggressive lymphomas Phase I: Dose escalation of methotrexate and cytarabine (days 1, 8 and 15 of each 28-day cycle) in a 3 + 3 design with fixed doses of lenalidomide (days 1 - 21) and rituximab (day 1), maximum 6 cycles Phase II: Treatment of 20 patients at maximum tolerated doses of phase I
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 |
|---|---|---|---|
| B-cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide
- description
- The LeMLAR protocol: Lenalidomide 25 mg p.o., days 1 - 21; Methotrexate 30 - 60 - 90 - 120 - 150 mg/m² i.v. bolus, days 1, 8, 15; Leucovorin 4 x 45 mg p.o. (every 6 hrs), days 2, 9, 16; Cytarabine (Ara-C) 75 - 150 - 225 - 300 - 375 mg/m² i.v. bolus, days 1, 8, 15; Rituximab 375 mg/m² i.v. infusion, day 1. 28-day cycles, maximum 6 cycles, definition of dose-limiting toxicity in cycles 1 and 2, intra-patient dose escalation after cycles 2 and 4 in case of absence of dose-limiting toxicity in previous cycles
- interventionNames
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- Dose-limiting toxicity
- timeFrame
- Two months
- description
- Phase I: Dose-limiting toxicity of the combination regimen, determination of the maximum tolerated doses of methotrexate and cytarabine Phase II: Overall response rate (percentage of complete and partial remissions combined)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Performance status ECOG 0 - 3 * First or subsequent relapse or refractoriness of a biopsy-proven CD20-positive aggressive B cell lymphoma (excluding mantle cell lymphoma) * Measurable disease * Ineligibility or unwillingness to undergo high-dose chemotherapy with autologous stem cell transplantation * Ability to understand the aim of the study and act accordingly * Effective contraception * Signed informed consent Exclusion Criteria: * Central nervous system relapse of aggressive lymphoma * Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study * Any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he/she were to participate in the study * Any condition that confounds the ability to interpret data from the study * Inadequate organ function not related to aggressive lymphoma: * neutrophils \< 1.0/nl * platelets \< 75/nl * creatinine clearance \< 60 ml/min * bilirubin ≥ 2,5 mg/dl * serum AST/GOT or ALT/GPT ≥ 4 x upper limit of normal * Active viral hepatitis (HBV, HCV), HIV infection, any other uncontrolled infection * Pregnancy and nursing period
References
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