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

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT01562990
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab, CMC544, Gemcitabine and Oxaliplatine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2012
Status verified
May 2016
Primary completion
Aug 31, 2014
Completion
Mar 31, 2016

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R-CMC544 and R-GEMOX
    Treatment with R-CMC544 and R-GEMOX

Primary Outcome Measure

Determination of the Recommended Dose of R-CMC544 [ Time Frame: Up to 16 weeks ]

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