The purpose of this study is to determine the efficacy and safety of ofatumomab in combination with ICE chemotherapy in subjects with relapsed/refractory DLBCL following failure to combination rituximab and anthracycline based chemotherapy. Participants with the option of potentially curative stem cell therapy may proceed to high dose chemotherapy and stem cell rescue. Participants with disease not considered curable with stem cell therapy, ineligible for or decline stem cell therapy may receive up to a maximum of 6 cycles of study drugs.
This is a Phase II, single-arm, non randomized, safety and efficacy study of ofatumumab in combination with salvage ICE chemotherapy (O-ICE) in 61 subjects with relapsed or refractory aggressive B cell lymphoma. O-ICE would be administered as an inpatient. The cycles are administered at 3 weeks intervals for ICE. Study subjects who are candidates for high dose chemotherapy (HDC) and autologous stem cell rescue (ASCR) would receive one or two more cycle of ICE salvage chemotherapy with ofatumumab before stem cell mobilization. G-CSF at 10 ug/kg per day after the third or forth cycle of treatment (at the discretion of the treating physician) would be administered until the end of leukapheresis for stem cell mobilization. After the third or forth cycle of salvage chemotherapy, leukapheresis was initiated until a collection of more than 5 x 106 CD34 cells/kg white blood or 5 procedures were performed, whichever occurred first. Collection of \<2x106 CD34+ cells/kg from peripheral blood will be considered mobilization failure for the purposes of the study. Leukapheresis and cryopreservation will be performed according to hospital practice. High dose chemotherapy will be administered as per our institution's protocol. Study subjects who are not candidates for HDC and ASCR would receive at most 6 cycles of salvage chemotherapy with ofatumumab. Subjects who progressed on treatment would be taken off study protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Ofatumab in combination with ICE (Ifosfamide, Carboplatin, Etoposide) are given to subjects according to protocol schedule
National Cancer Centre
Singapore, Singapore, Singapore
Response rate as measured by the new international criteria proposed by Cheason for response in non Hodgkin's lymphoma at the end of cycle 2 ofatumomab
Response (partial or complete response) status will be evaluated following two cycles of ofatumumab in combination with ICE chemotherapy
Time frame: 5 years
Progression free survival as measured from time of treatment start to time of disease progression
Progression evaluation will follow the new international criteria proposed by Cheason for response in non Hodgkin's lymphoma
Time frame: 5 years
Safety and tolerability of Ofatumomab in combination with ICE chemotherapy as measured by CTCAE
Adverse events will be graded following CTCAE (Common Terminology Criteria for Adverse Events) V4.03, and the relationship to the study treatment will be assessed by investigators.
Time frame: 5 years
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