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.
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
Determination of the Recommended Dose of R-CMC544
Determination of recommended dose will be based on safety parameters and particularly on incidence of DLTs
Up to 16 weeks
Fritz OFFNER, MD
Lymphoma Study Association
Belgium: Federal Agency for Medicinal Products and Health Products