NCT02412267

Study of Ofatumomab in Combination With ICE-chemotherapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

An Open-label, Non-randomized Phase 2 Study of Ofatumomab (O) in Combination With ICE (Ifosfamide, Carboplatin, Etoposide)-Chemotherapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	O-ICE (ofatumumab, Ifosfamide, Carboplatin, Etoposide)	Ofatumab in combination with ICE (Ifosfamide, Carboplatin, Etoposide) are given to subjects according to protocol schedule

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2015-04-09
• Last updated: 2016-03-23

Locations

1 site across 1 country: Singapore