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
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Tracking Information | ||||
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First Submitted Date ICMJE | March 13, 2015 | |||
First Posted Date ICMJE | March 26, 2015 | |||
Results First Submitted Date ICMJE | November 27, 2019 | |||
Results First Posted Date ICMJE | February 5, 2020 | |||
Last Update Posted Date | February 6, 2020 | |||
Study Start Date ICMJE | March 2016 | |||
Actual Primary Completion Date | November 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Participants With Best Objective Response Rate [ Time Frame: 1-3 years approximately ] ORR = complete response [CR] + partial response [PR]; IRC Evaluation
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Original Primary Outcome Measures ICMJE |
Objective response rate (ORR = complete response [CR] + partial response [PR]) [ Time Frame: 3 years ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL | |||
Official Title ICMJE | 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) | |||
Brief Summary | This is an open-label, multicentre study to characterize the safety and efficacy of the human anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Diffuse Large B-cell Lymphoma | |||
Intervention ICMJE |
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Study Arms ICMJE | 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. Interventions:
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Publications * | Salles G, Duell J, González Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, André M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
81 | |||
Original Estimated Enrollment ICMJE |
80 | |||
Estimated Study Completion Date ICMJE | November 2022 | |||
Actual Primary Completion Date | November 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Major Inclusion Criteria:
Major Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Spain, United Kingdom, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT02399085 | |||
Other Study ID Numbers ICMJE | MOR208C203 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | MorphoSys AG | |||
Study Sponsor ICMJE | MorphoSys AG | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | MorphoSys AG | |||
Verification Date | January 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |