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A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

NCT01271010 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2018-03-20

Study results available
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Summary

This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.

Conditions

  • Lymphocytic Leukemia, Chronic

Interventions

DRUG

Cyclophosphamide

Participants received cyclophosphamide 250 mg/m\^2 IV or 250 mg/m\^2 orally on Days 1-3 of each cycle.

DRUG

Fludarabine

Participants received fludarabine 25 mg/m\^2 IV or 40 mg/m\^2 orally on Days 1-3 of each cycle.

DRUG

Rituximab

Participants received 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle.

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
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-17
Primary Completion
2016-05-04
Completion
2016-05-04

Countries

  • Russia

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 NCT01271010 on ClinicalTrials.gov