Clinical trial · Interventional
A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
A Study of Chlorambucil Plus MabThera as Induction Therapy Followed in Responders by Maintenance Therapy Versus Observation on Response Rate in Patients >=60 Years With Previously Untreated Chronic Lymphocytic Leukemia
- 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 single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is \<100 individuals.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chlorambucil | Drug | Chlorambucil | ALIAS |
| rituximab [MabThera/Rituxan] | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: rituximab [MabThera/Rituxan]
- Drug: chlorambucil
Primary outcomes (1)
- measure
- Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment
- timeFrame
- Month 10
- description
- CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (\<) 4000/microliter (μL), neutrophils (PMN) greater than (\>) 1500/μL, platelets \>100,000/μL, and hemoglobin (Hb) \>11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) \<1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN \<1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age \<30 percent (%) lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN \>1500/μL, platelets \>100,000/μL or \>50% improvement from BL, and Hb \>11.0 g/dL or \>50% improvement from BL.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>=60 years of age; * CD20+ chronic lymphocytic leukemia (CLL); * no previous treatment for CLL; * ECOG performance status 0-1. Exclusion Criteria: * co-morbid conditions requiring long term use of systemic corticosteroids during study treatment; * history of severe cardiac disease; * transformation to aggressive B-cell malignancy.
References
Publications (0)
Data not yet available