Clinical Trials Logo
  1. Home
  2. Leukaemia, Lymphocytic, Chronic
  3. NCT00410163

Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients — BIFROST  

Leukaemia, Lymphocytic, Chronic Clinical Trial

Official title:
An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL

Clinical Trial Summary

To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00410163
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 2
Start date January 2007
Completion date May 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT01453062 - Phase IV Observational Study in Chronic Lymphocytic Leukemia N/A
Completed NCT01077622 - A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia Phase 2
Terminated NCT01039376 - Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy Phase 3
Completed NCT01110031 - Ofatumumab Cardiac Repolarization (QTc) Study in Fludarabine-Refractory Chronic Lymphocytic Leukemia Subjects Phase 1
Active, not recruiting NCT01520922 - Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL) Phase 2
Completed NCT00824265 - Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia Phase 3
Completed NCT00349349 - HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab Phase 2
Completed NCT00802737 - Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL) Phase 4
Terminated NCT00748189 - Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia Phase 3
Completed NCT01563055 - A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia Phase 2