NCT01370772

Intensified Rituimab Prephase Before FCR in Untreated B-CLL

Phase II Multicentric, Randomized Trial, Exploring Intensified Rituximab Prephase Monotherapy Before Standard Fludarabine-Cyclophosphamide-Rituximab Regimen in Previously Untreated Symptomatic B-cell Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Young fit medically B Cell untreated patients Comparison between FCR treatment = 6 FCR cycles and a the addition of a prephase with R Dense treatment before the 6 FCR cycles.

Conditions

• B-cell Chronic Lymphocytic Leukemia CLL

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-09-01
• Completion: 2016-03-01
• First posted: 2011-06-10
• Last updated: 2016-03-16

Locations

2 sites across 1 country: France