Lenalidomide Monotherapy in R/R DLBCL (RE-MIND)
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| ClinicalTrials.gov Identifier: NCT04150328 |
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Recruitment Status :
Recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
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Sponsor:
MorphoSys AG
Information provided by (Responsible Party):
MorphoSys AG
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Brief Summary:
This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)
| Condition or disease |
|---|
| Diffuse Large B Cell Lymphoma |
Tafasitamab (MOR00208) is currently in development for the treatment of R/R DLBCL. An ongoing, single-arm, phase II, open label, multicenter study (MOR208C203) is evaluating the efficacy and safety of tafasitamab combined with lenalidomide in patients with R/R DLBCL. In order to establish a lenalidomide monotherapy as a control cohort, this observational study aims to collect retrospective lenalidomide monotherapy data from real-world-evidence and to compare it with the tafasitamab-lenalidomide combination therapy.
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND) |
| Actual Study Start Date : | June 2, 2019 |
| Actual Primary Completion Date : | August 29, 2019 |
| Estimated Study Completion Date : | March 31, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Lenalidomide
Primary Outcome Measures :
- Best overall/objective response rate (ORR) [ Time Frame: Through study completion, an average of 9 months ]Proportion of patients with complete response (CR) or partial response (PR) as best response achieved at any time during the study
Secondary Outcome Measures :
- Overall survival [ Time Frame: Through study completion, an average of 9 months ]Time from treatment start until death from any cause
- Complete response rate [ Time Frame: Through study completion, an average of 9 months ]Proportion of patients having CR based on the best objective response achieved at any time during the study
- Disease control rate [ Time Frame: Through study completion, an average of 9 months ]Proportion of patients having CR, PR or stable disease (SD) based on the best objective response achieved at any time during the study
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
R/R DLBCL patients not eligible for HDC followed by ASCT who were treated with lenalidomide monotherapy
Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of DLBCL
- Relapsed/refractory to at least one previous systemic therapy for DLBCL
- Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL, including at least one anti-CD20 containing therapy
- Received lenalidomide monotherapy for R/R DLBCL while being considered not eligible for an ASCT
Exclusion Criteria:
- CNS involvement by lymphoma
- Patients who received lenalidomide in combination with another anti-lymphoma therapy (including radiation)
- Previously treated with anti-CD19-targeted therapy or immunomodulatory drugs
- Patients who previously underwent allogeneic SCT
- Known simultaneous detection of MYC and BCL2 or BCL6 translocation according to FISH
- Patients with a history of other malignancies within 5 years prior to lenalidomide treatment start
Information from the National Library of Medicine
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): NCT04150328
Contacts
| Contact: Sascha Tillmanns | +49 89 89927 ext 26520 | sascha.tillmanns@morphosys.com | |
| Contact: Stephan Parche | +49 89 89927 ext 26597 | stephan.parche@morphosys.com |
Locations
Show 57 study locations
Sponsors and Collaborators
MorphoSys AG
Investigators
| Study Director: | Sascha Tillmanns | MorphoSys AG |
| Responsible Party: | MorphoSys AG |
| ClinicalTrials.gov Identifier: | NCT04150328 |
| Other Study ID Numbers: |
MOR208C206 |
| First Posted: | November 4, 2019 Key Record Dates |
| Last Update Posted: | November 4, 2019 |
| Last Verified: | October 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Lenalidomide Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |