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

NCT02013817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2017-08-18

Study results available
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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.

Conditions

  • Lymphocytic Leukemia, Chronic

Interventions

DRUG

rituximab [MabThera/Rituxan]

Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8

DRUG

fludarabine

Every 4 weeks, 6 cycles

DRUG

cyclophosphamide

Every 4 weeks, 3 cycles

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-11
Primary Completion
2012-09-24
Completion
2012-09-24

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02013817 on ClinicalTrials.gov