A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL (L-MIND)
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|ClinicalTrials.gov Identifier: NCT02399085|
Recruitment Status : Active, not recruiting
First Posted : March 26, 2015
Results First Posted : February 5, 2020
Last Update Posted : February 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma||Drug: MOR00208 Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2022|
Experimental: Treatment (MOR00208, lenalidomide)
MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.
Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Other Name: MOR208
- Number of Participants With Best Objective Response Rate [ Time Frame: 1-3 years approximately ]ORR = complete response [CR] + partial response [PR]; IRC Evaluation
- Disease Control Rate (DCR) [ Time Frame: 1-3 years approximately ]DCR = CR + PR + SD; IRC Evaluation
- Duration of Response (DoR) [ Time Frame: 1-3 years approximately ]IRC Evaluation
- Progression-free Survival (PFS) [ Time Frame: 1-3 years approximately ]IRC Evaluation
- Percentage of Participants With Overall Survival (OS) [ Time Frame: Approximately 32 months between first patient first visit and primary outcome completion date ]Overall survival was defined as first administration of IMP and deaths due to any cause. Percentage of patients alive at 12 months from the start of their study participation is reported.
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): NCT02399085
|Study Director:||Sumeet V Ambarkhane, MD||Clinical Program Leader|