CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy

Sponsor
Hoffmann-La Roche
Study ID
NCT02013817
Phase
PHASE2
Status
Completed

Conditions

  • Lymphocytic Leukemia, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab [MabThera/Rituxan] — DRUG
    Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8
  • fludarabine — DRUG
    Every 4 weeks, 6 cycles
  • cyclophosphamide — DRUG
    Every 4 weeks, 3 cycles

Study Details

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.

Key Dates

Start date
Oct 11, 2005
Status verified
Jul 2017
Primary completion
Sep 24, 2012
Completion
Sep 24, 2012

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MabThera/Rituxan

Primary Outcome Measure

Percentage of Participants With a Best Clinical Response of Clinical Remission (CR) [ Time Frame: Weeks 1, 5, 9, 12, 13, 17, 21 and 24 ]

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