GSK OMB 110911
Trial overview
A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukaemia
Primary Outcome Measures:
•Progression-free-survival (PFS)
Secondary Outcome Measures:
•Overall response rate
•Overall survival
•Clinical benefit, safety, tolerability, changes in patient reported outcome measures and pharmacokinetics
Inclusion criteria
• Patients with confirmed and active CLL requiring treatment
• Not been treated for CLL before
• Fully active at a minimum or fully capable of self care and up and about more than 50% of waking hours
• Age 18yrs or older
• Signed written informed consent
Exclusion criteria
• Prior CLL therapy
• Abnormal/inadequate blood values, liver, and kidney function
• Certain heart problems, active or chronic infections, serious significant diseases, AIHA, other current cancer or within last 5 years
• CLL transformation
• CLL central nervous system involvement
• Current participation in other clinical study
• Inability to comply with the protocol activities
• Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Contact details
Other trials currently active for Chronic Lymphocytic Leukaemia
Does the Addition of Mitoxantrone Improve Response to FCR chemotherapy in patients with CLL: A randomised Phase II Trial of fludarabine, cyclophosphamide and rituximab (FCR) with or without mitoxantrone (M) in previously untreated chronic lymphocytic leukaemia
Genetic study of B-cell chronic lymphocytic leukaemia and other lymphoproliferative disease.
CLL Lenalidomide Maintanence 002 - The Continuum Trial
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) AS MAINTENANCE THERAPY FOR PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA FOLLOWING SECOND-LINE THERAPY (The Continuum Trial)
Attenuated dose Rituximab with ChemoTherapy In CLL: A randomised, phase IIB trial in previously untreated patients with Chronic Lymphocytic Leukaemia (CLL) to compare fludarabine, cyclophosphamide and rituximab (FCR) with FC, mitoxantrone and low dose rituximab (FCM-miniR)
A Phase 2, Multi-Center, Randomized, Double-Blind, Parallel-Group Study Of The Safety And Efficacy Of Different Lenalidomide (Revlimid®) Dose Regimens In Subjects With Relapsed Or Refractory B-Cell Chronic Lymphocytic Leukemia.
Phase II single-arm NCRI feasibility study of CHOP in combination with ofatumumab in induction and maintenance of patients with newly diagnosed Richter's Syndrome.
The CHOP-OR trial is intended to discover whether the combination of chemotherapy and ofatumumab improves outcomes compared to chemotherapy alone, and also whether there are any rare side effects of ofatumumab in combination with chemotherapy which we do not know about.
Tags
phase iii cll open label chronic lymphocytic leukaemia randomized ofatumumab chlorambucil chlorambucil versus monotherapy