Leukaemia, Lymphocytic, Chronic Clinical Trial
Official title:
A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia
The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).
Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia.
Studies have shown that drugs in combination with fludarabine have shown more effectiveness
than fludarabine alone. The addition of ofatumumab to fludarabine-cyclophosphamide
combination offers potentially a more effective therapy, without additional toxicity.
The objective of this study was to determine the effect of ofatumumab added to fludarabine
and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded
previously to therapy but later develop progressive disease and require additional therapy.
;
| 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 |
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 | |
| 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 |