Phase 2 Inotuzumab Ozogamicin plus Rituximab in DLBCL
Research type
Research Study
Full title
An open-label, single arm, phase 2 study of Inotuzumab Ozogamicin plus Rituximab in subjects with relapsed/refractory CD22-Positive Diffuse Large B-Cell Lymphoma, eligible for autologous stem cell transplantation
IRAS ID
22712
Contact name
John Radford
Sponsor organisation
Wyeth Research
Eudract number
2008-007802-12
Clinicaltrials.gov Identifier
Research summary
Diffuse large B-cell lymphoma (DLBCL) is an aggressive cancer of the lymphatic system (part of the immune system) that is invariably fatal without treatment. Modern chemotherapy regimens containing the anti-B-cell antibody Rituximab, such as R-CHOP, will produce good responses in 75% and can cure around 50% of patients. The remainder however will unfortunately progress through or relapse following first line chemotherapy. Traditionally these patients would have a second line of chemotherapy, which if successful in shrinking the disease down (remission), will then go on to have a type of bone marrow transplant called an autograft to consolidate this remission. However, second line chemo only achieves this in approximately 20% of relapsers, as the disease has frequently become resistant to conventional chemotherapy by this point. Most of the patients in this situation will go on to die of their disease. Inotuzumab ozogomicin is a novel anti-cancer agent that is specifically designed to attack DLBCL cells in a different way from chemotherapy. It is therefore hoped that it might be effective in relapsed patients who could be predicted to have a poor response to standard second line chemo. This study will invite a selection of these poor prognosis patients to receive 3 injections of Inotuzumab ozogomicin, once every 3 weeks. Those whose lymphomas respond (shrink) satisfactorily will go on to have their remission consolidated by an autograft (bone marrow stem cell transplant). The overall aims are therefore to assess A) the effectiveness and B) the safety of this drug in this setting. Patients whose lymphomas are predicted to respond well to second line chemo will not be eligible.
REC name
North West - Haydock Research Ethics Committee
REC reference
09/H1010/66
Date of REC Opinion
9 Nov 2009
REC opinion
Further Information Favourable Opinion