Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)

Leukaemia, Lymphocytic, Chronic Clinical Trial

Official title:
A Single-arm, International, Multi-center Trial Investigating the Efficacy and Safety of Ofatumumab Retreatment and Maintenance in CLL Patients Who Progressed Following Response or Stable Disease After Ofatumumab Treatment in Hx-CD20-406

Status Completed

Clinical Trial Summary

The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment and maintenance in patients with chronic lymphocytic leukemia who have previously responded or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Leukaemia, Lymphocytic, Chronic
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid

Clinical Trial Details

NCT number	NCT00802737
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 4
Start date	January 2009
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	`NCT00410163` - Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients	Phase 2
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