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A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

NCT02533401 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-05-02

Study results available
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Summary

This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.

Conditions

  • Lymphocytic Leukemia, Chronic

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide will be administered IV at 250 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

DRUG

Fludarabine

Fludarabine will be administered IV at 25 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

DRUG

Rituximab

Rituximab will be administered IV at 375 mg/m\^2 on Day 1 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

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
2006-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Argentina
  • Venezuela

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 NCT02533401 on ClinicalTrials.gov