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Intensified Rituimab Prephase Before FCR in Untreated B-CLL

NCT01370772 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2016-03-16

No results posted yet for this study

Summary

Phase II, multicenter, randomized trial, exploring intensified Rituximab prephase monotherapy before standard Fludarabine-Cyclophosphamide-Rituximab FC-R regimen in previously untreated symptomatic B-cell chronic lymphocytic leukemia CLL.

A Study from the Goelams GCFLLCMW intergroup

Conditions

  • B-cell Chronic Lymphocytic Leukemia CLL

Interventions

DRUG

Rituximab

* Cycle 1 Rituximab : 375 mg/m² i.v on day 1 * Cycle 2-6 Rituximab:500 mg/m² i.v on day 1, repeated every 28 days

DRUG

Rituximab

* Prephase: Rituximab:500 mg on day 0, 2000 mg on days 1, 8, and D15 * Cycle 1-6 cycle 1 beginning at D22: Rituximab: 500 mg/m2 i.v on day 1, repeated every 28 days

DRUG

Cyclophosphamide

•FCR Cycle 1-6: Cyclophosphamide : 250 mg/m² per os, days 2-4, repeated every 28 days

DRUG

Fludarabine

FCR Cycle 1-6: Fludarabine :40 mg/m² per os, days 2-4, repeated every 28 days

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Guillaume CARTRON, MD PD · French Innovative Leukemia Organisation

  • Stephane LEPRETRE, MD · French Innovative Leukemia Organisation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-09-30
Completion
2016-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT01370772 on ClinicalTrials.gov