Clinical trial · Interventional
A Study of MabThera (Rituximab) Plus Chlorambucil in Participants With Chronic Lymphocytic Leukemia.
An Open-Label Study to Characterize the Safety and Response Rate of MabThera (Rituximab) Plus Chlorambucil in Previously Untreated Patients With CD20-Positive B-Cell 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 safety and effect on response rate of a combination of rituximab and chlorambucil in previously untreated participants with B-cell chronic lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment, followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of each cycle, at a dose of 375 milligrams per square meter (mg/m\^2) intravenously (IV) in Cycle 1, and 500 mg/m\^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of each cycle at a dose of 10 mg/m\^2/day per oral (PO).
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 | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab plus Chlorambucil
- description
- Participants will receive combination therapy of rituximab plus chlorambucil for first 6 cycles and then chlorambucil alone for a maximum of 6 additional cycles.
- interventionNames
- Drug: Rituximab
- Drug: Chlorambucil
Primary outcomes (1)
- measure
- Percentage of Participants With Treatment-Emergent Adverse Events (AEs)
- timeFrame
- First administration of study treatment up to 56 days after the beginning of the last treatment cycle (up to 365 days)
- description
- An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 56 days from the beginning of the last treatment cycle that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs as well as non-serious AEs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * previously untreated participants with cluster of differentiation 20 (CD20) positive B-cell chronic lymphocytic leukemia; * participants with progressive Binet stage B, or C requiring therapy according to National Cancer Institute (NCI) criteria; * Eastern Cooperative Oncology Group (ECOG) performance status \<=2. Exclusion Criteria: * previous treatment for Chronic Lymphocytic Leukaemia (CLL); * known concomitant hematological malignancy; * transformation to aggressive B-cell malignancy; * history of severe cardiac disease; * known hypersensitivity or anaphylactic reactions to murine antibodies.
References
Publications (1)
- DERIVEDHillmen P, Gribben JG, Follows GA, Milligan D, Sayala HA, Moreton P, Oscier DG, Dearden CE, Kennedy DB, Pettitt AR, Nathwani A, Varghese A, Cohen D, Rawstron A, Oertel S, Pocock CF. Rituximab plus chlorambucil as first-line treatment for chronic lymphocytic leukemia: Final analysis of an open-label phase II study. J Clin Oncol. 2014 Apr 20;32(12):1236-41. doi: 10.1200/JCO.2013.49.6547. Epub 2014 Mar 17. PMID 24638012