Diffuse Large B-Cell Lymphoma Clinical Trial
Official title:
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.
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.
This study is a multicenter, phase Ib/II, open-label, single arm trial evaluating the
efficacy and safety of R-CMC544 alternated with R-GEMOX in patients with CD20 and CD22
positive DLBCL in relapse after/refractory to 1st or 2nd line treatment, who are no
candidates for autologous transplant.
The study consists of 2 phases. In part 1 (potential dose de-escalation phase) subjects will
be enrolled at a fixed dose of CMC544. In case of occurrence of dose limiting toxicity
(DLT), cohorts of 3 to 6 subjects will evaluate a de-escalating dose of CMC544 in
combination with set doses of rituximab, gemcitabine and oxaliplatin in order to obtain the
MTD or recommended dose of CMC544 in this regimen. In part 2 (dose expansion phase) further
safety and preliminary efficacy data of the proposed combination will be analyzed.
All patients will receive two 56 day induction cycles of alternating R-CMC544 (given on day
1) and R-GEMOX (given on day 29 and 43). Patients who obtain CR or PR, will then go on a
consolidation of another two 56 day cycles of alternating R-CMC544 (given on day 1) and
R-GEMOX (given on day 29 and 43).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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