Phase Ib/II Study of the Efficacy and Safety of the R-CMC544/R-GEMOX Combination in Diffuse Lage B-cell Lymphoma at First or Second Relapse
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|ClinicalTrials.gov Identifier: NCT01562990|
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : May 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-Cell Lymphoma||Drug: Rituximab, CMC544, Gemcitabine and Oxaliplatine||Phase 1 Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||March 2016|
Experimental: R-CMC544 and R-GEMOX
Treatment with R-CMC544 and R-GEMOX
Drug: Rituximab, CMC544, Gemcitabine and Oxaliplatine
2 cycles of induction of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43.
2 cycles of consolidation of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43.
- Determination of the Recommended Dose of R-CMC544 [ Time Frame: Up to 16 weeks ]Determination of recommended dose will be based on safety parameters and particularly on incidence of DLTs
- OVERALL RESPONSE RATE [ Time Frame: Up to 32 weeks ]Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 1999 and 2007). Patient is defined as a responder if he/she has a complete response (CR) or partial response (PR) at the end of treatment. A descriptive analysis will also be performed considering as non-responders all patients who relapsed or died during treatment phase even if they were prematurely withdrawn as responder
- PROGRESSION-FREE SURVIVAL [ Time Frame: Up to 3.5 years ]Progression-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.
- EVENT FREE SURVIVAL [ Time Frame: Up to 3.5 years ]Event-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.
- OVERALL SURVIVAL [ Time Frame: Up to 3.5 years ]Overall survival will be measured from the date of inclusion to the date of death from any cause. Patients who are alive at the time of analysis will be censored at the date of the last contact.
- COMPLETE RESPONSE RATE [ Time Frame: 30 or 32 weeks (depending on induction cycle length) ]
Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 2007)).
Patient without response assessment (due to whatever reason) will be considered as nonresponder.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562990
|AZ Sint Jan|
|Bruges, Belgium, 8000|
|University Hospital Gent|
|Gent, Belgium, 9000|
|Hôpital Henri Mondor|
|Créteil, France, 94010|
|CHU de Dijon|
|Dijon, France, 21000|
|CHRU de Lille|
|Lille, France, 59037|
|CHU Lyon - Sud|
|Lyon, France, 69495|
|CHU Hôtel Dieu|
|Nantes, France, 44093|
|Rennes, France, 35003|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Vandoeuvre les nancy, France, 54511|
|Study Chair:||Fritz OFFNER, MD||Lymphoma Study Association|
|Study Chair:||Corinne HAIOUN, PhD||Lymphoma Study Association|