Intensified Rituimab Prephase Before FCR in Untreated B-CLL

Conditions

• B-cell Chronic Lymphocytic Leukemia CLL

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  * 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
• Rituximab — DRUG
  * 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
• Cyclophosphamide — DRUG
  •FCR Cycle 1-6: Cyclophosphamide : 250 mg/m² per os, days 2-4, repeated every 28 days
• Fludarabine — DRUG
  FCR Cycle 1-6: Fludarabine :40 mg/m² per os, days 2-4, repeated every 28 days

Study Details

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

Key Dates

Start date

May 31, 2011

Status verified

Mar 2016

Primary completion

Sep 30, 2014

Completion

Mar 31, 2016

Study Design

Enrollment

140 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard R-FC arm
  Standard R-FC arm 6 cycles every 28 days * Cycle 1: * Rituximab : 375 mg/m² i.v on day 1 * Fludarabine : 40 mg/m² per os, days 2-4, repeated every 28 days * Cyclophosphamide : 250 mg/m² per os, days 2-4, repeated every 28 days For patients with Leucocyte count \> 25\* G/L : rituximab in two equal doses at D1, D2 * Cycle 2-6: * Rituximab: 500 mg/m² i.v on day 1, repeated every 28 days * Fludarabine : 40 mg/m² per os, days 2-4, repeated every 28 days * Cyclophosphamide : 250 mg/m² per os, days 2-4, repeated every 28 days
• Experimental: DenseR-FC arm
  DenseR-FC arm =1 prephase R Dense course +6 R-FC courses * Prephase: \- Rituximab: 500 mg on day 0, 2000 mg on days 1, 8, and D15 For patients with Leucocyte count \> 25\* G/L : rituximab 250 mg D-1, D0 prephase * Cycle 1-6 (cycle 1 beginning at D22): * Rituximab: 500 mg/m2 i.v on day 1, repeated every 28 days * Fludarabine : 40 mg/m² per os, days 2-4, repeated every 28 days * Cyclophosphamide : 250 mg/m² per os, days 2-4, repeated every 28 days

Primary Outcome Measure

complete response rates according to IWCLL 2008 guidelines with undetectable minimal residual disease [ Time Frame: 9 months ]