Clinical trial · Interventional
A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
Prospective Randomized Study to Compare Efficacy and Safety of RFC-Lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
- 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)
This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously \[IV\] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment was 24 weeks.
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 |
|---|---|---|---|
| Lymphocytic Leukemia, Chronic | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorambucil | Drug | Chlorambucil | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FCR-lite
- description
- Rituximab, fludarabine, and cyclophosphamide
- interventionNames
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Rituximab
- type
- ACTIVE_COMPARATOR
- label
- LR Therapy
- description
- Rituximab and chlorambucile
- interventionNames
- Drug: Chlorambucil
- Drug: Rituximab
Primary outcomes (10)
- measure
- Percentage of Participants With Complete Remission
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, 60-70 or \>70 years of age * Cumulative Illness Rating Scale (CIRS) comorbidity score \>/=7 if patient is 60-70 years old * Previously untreated B-cell chronic lymphocytic leukemia * Binet stage B, C or A with progression * ECOG performance status 0-2 Exclusion Criteria: * Small-cell lymphoma * Autoimmune hemolytic anemia * Concomitant malignant disease during enrollment, except for basal cell carcinoma of the skin * Chemotherapy for concomitant malignant disease within 12 months prior to study enrollment * Richter's syndrome
References
Publications (0)
Data not yet available