Phase 2
Completed N=100
A Study of MabThera (Rituximab) Plus Chlorambucil in Participants With Chronic Lymphocytic Leukemia.
Lymphocytic Leukemia, Chronic
Source: ClinicalTrials.gov NCT00532129 ↗
Enrolled (actual)
100
Serious AEs
39.0%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) — 99 percentage of participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) |
99 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) of Clinical CR or Confirmed CR |
37.0; 10.0; 47.0 | — |
| SECONDARY Percentage of Participants With BOR of Partial Response (PR) |
68.0 | — |
| SECONDARY Percentage of Participants With BOR of Nodular Partial Response (nPR) |
6.0 | — |
| SECONDARY Percentage of Participants With BOR of Progressive Disease (PD) |
4.0 | — |
| SECONDARY Percentage of Participants With BOR of Stable Disease (SD) |
11.0 | — |
| SECONDARY Percentage of Participants With Objective Response (CR or PR) |
84.0 | — |
| SECONDARY Percentage of Participant With Disease Progression or Death |
68.0 | — |
| SECONDARY Progression Free Survival (PFS) Time |
716.5 | — |
| SECONDARY Disease Free Survival (DFS) Time |
855.0 | — |
| SECONDARY Duration of Response (DoR) |
645.0 | — |
| SECONDARY Percentage of Participants Who Died |
15.0 | — |
| SECONDARY Overall Survival (OS) Time |
NA | — |
| SECONDARY Percentage of Participants Who Achieved Minimal Residual Disease (MRD) Negativity |
0.0 | — |
| SECONDARY Mean Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores |
65.7; 6.4; 6.2; 2.0; 77.0; 1.0 | =0.029 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00532129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.