Phase 2
Completed N=34
A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
Lymphocytic Leukemia, Chronic
Source: ClinicalTrials.gov NCT02533401 ↗
Enrolled (actual)
34
Serious AEs
44.1%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants With Death or Disease Progression — 24 percentage of participants
Summary
This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Death or Disease Progression |
24 | — |
| PRIMARY Progression-Free Survival (PFS) |
47.2 | — |
| PRIMARY Percentage of Participants Who Died |
14 | — |
| PRIMARY Overall Survival (OS) |
49.5 | — |
| PRIMARY Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR) |
71; 9; 18 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants greater than or equal to (≥) 18 years of age
- B-cell CLL
- No previous treatment for leukemia
Exclusion Criteria
- History of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer
- Comorbid condition requiring long-term (greater than [>] 1 month) systemic corticosteroids during study treatment
- Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT02533401). 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.