Phase 2
Completed N=43
CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
Lymphocytic Leukemia, Chronic
Source: ClinicalTrials.gov NCT02013817 ↗
Enrolled (actual)
43
Serious AEs
69.8%
Results posted
Sep 2014
Primary outcomePrimary: Percentage of Participants With a Best Clinical Response of Clinical Remission (CR) — 73.7; 94.7; 63.2; 78.9 percentage of participants
Summary
This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Best Clinical Response of Clinical Remission (CR) |
73.7; 94.7; 63.2; 78.9 | — |
| SECONDARY Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment) |
41.9; 16.3; 16.3; 11.6; 2.3; 0.0 | — |
| SECONDARY Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment) |
30.2; 4.7; 7.0; 30.2; 9.3; 7.0 | — |
| SECONDARY Time to Next Treatment - Percentage of Participants With an Event |
37.2 | — |
| SECONDARY Time to Next Treatment - Time to Event |
423.3 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
100; 93.0; 76.7; 62.8; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- B-cell CLL
- No previous chemotherapy, radiotherapy, or immunotherapy
Exclusion Criteria
- Reduced organ function, or bone marrow dysfunction not due to CLL
- Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer
- Patients with a history of severe cardiac disease.
Data sourced from ClinicalTrials.gov (NCT02013817). 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.