Phase 2
Completed N=86
A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)
Source: ClinicalTrials.gov NCT00545714 ↗Enrolled (actual)
86
Serious AEs
40.7%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants With CR Achieved After the Rituximab, Fludarabine, and Cyclophosphamide Regimen — 95.2 Percentage of Participants
Summary
This single arm study will assess the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line treatment of participants with CLL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With CR Achieved After the Rituximab, Fludarabine, and Cyclophosphamide Regimen |
95.2 | — |
| SECONDARY Percentage of Participants With Clinical Response of CR or PR as Assessed by Multiparameter Flow Cytometry |
75.0; 13.1; 89.4; 6.4; 87.9; 6.1 | — |
| SECONDARY Percentage of Participants With Clinical Response of CR or PR Among Participants With Negative Minimal Residual Disease (MRD) as Assessed by Multiparameter Flow Cytometry |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With CR With Incomplete Bone Marrow Recovery (CRi) |
7.1 | — |
| SECONDARY Percentage of Participants Who Died |
23.2 | — |
| SECONDARY Overall Survival (OS) |
7.51 | — |
| SECONDARY Percentage of Participants With PD or Death |
39.29 | — |
| SECONDARY Progression-Free Survival (PFS) |
6.96 | — |
| SECONDARY Treatment-Free Survival (TFS) |
4.13 | — |
| SECONDARY Duration of Response (DOR) |
NA | — |
| SECONDARY Percentage of Participants With Cluster of Differentiation (CD) 38 Cells >/=30% in Peripheral Blood |
47.6; 44.4; 45.5; 47.6; 47.4; 66.7 | — |
| SECONDARY Percentage of Participants With Genetic Abnormalities |
3.6; 26.2; 4.8; 15.5; 50.0; 4.3 | — |
| SECONDARY Percentage of Participants With Positive and Negative Zeta-Chain-Associated Protein Kinase 70 (ZAP-70) Expression |
57.3; 42.7; 57.5; 42.5; 62.1; 37.9 | — |
| SECONDARY Percentage of Participants With Immunoglobulin Heavy Locus (IgH) Rearrangement |
36.2; 37.1; 20.0; 29.4; 33.3; 100.0 | — |
Eligibility Criteria
Inclusion Criteria
- CLL according to World Health Organization diagnostic criteria
- Active disease
- No previous treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Exclusion Criteria
- Transformation to aggressive B-cell malignancy (prolymphocytic leukemia, large-cell lymphoma, Hodgkin's lymphoma)
- Other malignancies except for localized skin cancer
- Continuous systemic corticosteroid treatment
- Known infection with hepatitis B or C
Data sourced from ClinicalTrials.gov (NCT00545714). 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.