Trial intelligence / Profile preview

FFP and Rituximab in Advanced Refractory CLL

NCT00892827Phase 2

Key facts

Status
Unknown
Start
Apr 2009
Primary completion
Jul 2009
Countries
1
Sponsor
Edith Wolfson Medical Center
Modality
Monoclonal Antibodies
Conditions
chronic lymphocytic leukemia (CLL)
01

Overview

Phase 2, open-label, single-arm trial of rituximab in chronic lymphocytic leukemia (CLL), sponsored by Edith Wolfson Medical Center. Primary endpoint: Complete/Partial Response Rate at 3 months. Status: unknown.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Rituximab + FFP

    Rituximab (375 mg/m2) + Fresh Frozen Plasma (2 units)

03

Who it enrols

Patients with advanced refractory CLL (Rai stage >=2 or symptomatic stage 1) resistant to Fludarabine/Rituximab, with high lymphocyte counts (>= 100,000/mcl).

04

Endpoints

Primary

  • Complete/Partial Response Rate

Secondary

  • Time to Disease Progression

  • Time to Re-treatment

  • Safety of Combination Treatment

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