Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL (RE-MIND2)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04697160
Recruitment Status : Completed
First Posted : January 6, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To compare the efficacy outcomes of the L-MIND cohort with the effectiveness in a matched patient population treated with systemic NCCN/ESMO guideline listed regimens administered in routine clinical care.

Condition or disease
Diffuse Large B Cell Lymphoma

Detailed Description:
This retrospective observational cohort study aims to generate a historical control consisting of R/R DLBCL patients who received currently guideline recommended therapies.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 3573 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Retrospective Cohort Study of Systemic Therapies for Relapsed or Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL), to Compare Outcomes to Those From Tafasitamab + Lenalidomide in the L-MIND Study
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : May 7, 2021
Actual Study Completion Date : May 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Patients who received systemic therapies for R/R DLBCL


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Overall/Objective Response Rate (ORR) [ Time Frame: through study completion, an average of 1 year ]
  2. Complete Response Rate (CR) [ Time Frame: through study completion, an average of 1 year ]
  3. Duration of Response (DoR) [ Time Frame: through study completion, an average of 1 year ]
  4. Event Free Survival (EFS) [ Time Frame: through study completion, an average of 1 year ]
  5. Progression Free Survival (PFS) [ Time Frame: through study completion, an average of 1 year ]
  6. Time to next treatment (TTNT) [ Time Frame: through study completion, an average of 1 year ]
  7. Treatment discontinuation rate due to adverse events [ Time Frame: through study completion, an average of 1 year ]
  8. Duration of treatment exposure [ Time Frame: through study completion, an average of 1 year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Patients with relapsed or refractory DLBCL
Criteria

Eligibility Criteria:

  1. Age ≥ 18 years at the initial DLBCL diagnosis.
  2. One of the following histologically confirmed diagnosis: DLBCL not otherwise specified (NOS); T-cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma (FL), Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as FL, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
  3. Relapsed or refractory DLBCL and received at least 2 systemic regimens for the treatment of DLBCL, including at least 1 anti-CD20 containing therapy.

Non-Eligibility Criteria:

  1. Patients with central nervous system (CNS) involvement by lymphoma at initial DLBCL diagnosis.
  2. Patients who were treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs) (e.g., thalidomide, LEN) as a frontline DLBCL therapy.
  3. Patients who underwent an allogeneic stem cell transplant.

  4. Patients who had a prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥5 years prior to inclusion.

    Note: Patients with the following malignancies within the 5 years period are still eligible:

    1. basal cell carcinoma of the skin
    2. squamous cell carcinoma of the skin
    3. carcinoma in situ of the cervix
    4. carcinoma in situ of the breast
    5. carcinoma in situ of the bladder
    6. incidental histological finding of prostate cancer (Tumor/Node/Metastasis [TNM] stage of T1a or T1b)
  5. Patients who received tafasitamab.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04697160


Locations
Show Show 166 study locations
Sponsors and Collaborators
MorphoSys AG
Investigators
Layout table for investigator information
Study Director: Eva Waltl MorphoSys AG
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT04697160    
Other Study ID Numbers: MOR208C213
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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