A Multi-center, Phase IB/II, Open Label, Single Arm Study of Inotuzumab Ozogamicin Plus Rituximab (R-CMC544) Alternating With Gemcitabine-oxaliplatin Plus Rituximab(R-GEMOX)in Patients Aged From 18 to 80 Years With CD20 and CD22 Positive Diffuse Large B-cell Lymphoma (DLBCL) in Relapse After/Refractory to 1ST or 2ND Line Treatment, Who Are no Candidates for Autologous Transplant.

NCT01562990 Phase 1/Phase 2 COMPLETED

The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of this combination will be evaluated preliminarily in patients with DLBCL in relapse or refractory, who are no candidates for autologous transplant.

Details

Lead sponsor	The Lymphoma Academic Research Organisation
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	11
Start date	2012-12
Completion	2016-03

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

• Rituximab, CMC544, Gemcitabine and Oxaliplatine

Primary outcomes

• Determination of the Recommended Dose of R-CMC544 — Up to 16 weeks
  Determination of recommended dose will be based on safety parameters and particularly on incidence of DLTs

Countries

Belgium, France