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Lenalidomide Monotherapy in R/R DLBCL (RE-MIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04150328
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

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

Detailed Description:
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.

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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





Primary Outcome Measures :
  1. 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 :
  1. Overall survival [ Time Frame: Through study completion, an average of 9 months ]
    Time from treatment start until death from any cause

  2. 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

  3. 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



Information from the National Library of Medicine

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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
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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 Show 57 study locations
Sponsors and Collaborators
MorphoSys AG
Investigators
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Study Director: Sascha Tillmanns MorphoSys AG

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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

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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