Study of CHOP with Ofatumumab in patients with Richter's Syndrome V1.0
Research type
Research Study
Full title
Single arm NCRI feasibility study of CHOP in combination with Ofatumumab in induction and maintenance for patients with newly diagnosed Richter’s Syndrome
IRAS ID
56642
Contact name
Anna Schuh
Sponsor organisation
University of Oxford
Eudract number
2009-016459-23
ISRCTN Number
Not applicable
Clinicaltrials.gov Identifier
Research summary
Richterms Syndrome (RS) is a high-grade transformation that occurs in 5-15% of patients with B cell chronic lymphocytic leukaemia (B-CLL). RS is a complication of B-CLL in which the leukemia changes into a fast-growing diffuse large B cell lymphoma. The pathoGenesis (Mechanism by which the disease is caused) of RS is poorly understood and predictors of transformation and response to treatment are unknown. Management of RS remains unsatisfactory; the mean overall survival of patients treated with conventional chemo-immunotherapy such as CHOP-R is 8 months from the end of treatment.CHOP is the acronym for a chemotherapy regimen, cyclophosphamide, hydroxydaunorubicin (doxorubicin), Oncovin (vincrestine), and prednisone/prednisolone) and the restan's for the monoclonal antibody, Rituximab. Ofatumumab, a next generation monoclonal anti CD20 antibody, has proven'single agent activity in relapsed/refractory B-CLL and other non-Hodgkin lymphomas. In addition, it has shown a favourable safety profile in the maintenance setting. Therefore, we propose to evaluate Ofatumumab in combination with CHOP in induction and maintenance treatment of patients with RS. The primary objective of the study will be to evaluate overall response rate (ORR) to CHOP-O (CHOP chemotherapy plus Ofatumumab) according to the Revised response Criteria for Malignant Lymphoma (Cheson).Secondary objectives will be feasibility of recruitment, progression free survival and overall survival, the clinical benefit and changes in patient reported outcome measures, safety and tolerability.This is a multi-centre non-randomised Phase II NCRI feasibility study in 35 patients with newly diagnosed RS in the UK. CHOP-O will be given formsix cycles followed by six cycles of Ofatumumab maintenance treatment every eight weeks and a three months follow-up period. The total duration of recruitment will be 24 months starting from the opening of the first site.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
10/H0604/85
Date of REC Opinion
13 Jan 2011
REC opinion
Further Information Favourable Opinion