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realMIND: Observational Study of Patients With Relapsed or Refractory DLBCL Starting Second- or Third-line Therapy (realMIND)

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ClinicalTrials.gov Identifier: NCT04981795
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : May 31, 2022
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
MorphoSys AG

Study Description
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Brief Summary:
REAL-MIND: Prospective multicenter observational study of patients with relapsed or refractory diffuse large B-cell lymphoma starting second- or third-line therapy and not receiving autologous stem cell transplant

Condition or disease
Diffuse Large B-cell Lymphoma

Detailed Description:

The purpose of this study is to assess treatment patterns, physician reported clinical outcomes and patient-reported health-related quality of life (HRQoL) among patients diagnosed with R/R-DLBCL not receiving autologous stem cell transplant (ASCT) and initiating second- or third-line therapy. In addition, the aim of the Real-MIND study is to enroll patients belonging to racial and ethnic minorities with a good gender, age and socio-economic status balance in order to gain the best representation of the US population.

This non-interventional study will collect real-world data on treatments and clinical outcomes as per usual care. This protocol does not recommend the use of any specific treatments or assessments.

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: realMIND: Observational Study of Patients With Relapsed or Refractory DLBCL Starting Second- or Third-line Therapy and Not Receiving Autologous Stem Cell Transplant
Actual Study Start Date : September 20, 2021
Estimated Primary Completion Date : July 15, 2028
Estimated Study Completion Date : July 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Group/Cohort
Adults (> or = 18 years of age)
Adults (> or = 18 years of age) diagnosed with relapsed or refractory DLBCL and initiating second- or third-line therapy meeting inclusion criteria.


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Patterns [ Time Frame: 2 Years ]

    Number and percentage of treatment regimens used in R/R-DLBCL patients

    • Number and percentage of different regimen sequences
    • Treatment characteristics: Line of therapy, Treatment regimen, Treatment dosage,


Secondary Outcome Measures :
  1. Physician-reported clinical outcomes [ Time Frame: 2 Years ]
    Treatment effectiveness among R/R-DLBCL patients: Response assessment; criteria and imaging method used as reported by treating physician: DoR, ORR, CR, OS, EFS


Eligibility Criteria
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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:   Probability Sample
Study Population
Community Study- 75 sites across the USA
Criteria

Inclusion Criteria:

  • Signed and dated informed consent by the patient or the patient's Legally Acceptable Representative (LAR)
  • Age ≥18 years old at time of diagnosis of R/R-DLBCL
  • Histologically confirmed diagnosis of DLBCL according to World Health Organization (WHO) classification, including histologically confirmed diagnosis of high-grade lymphoma with double and triple hit: DLBCL with MYC and BCL2/BCL6 translocation (double-hit) and MYC and BCL2 and BCL6 translocations (triple-hit)
  • Availability of data on first-line (and second-line, if applicable) DLBCL therapy (with the minimum data required including treatment type, number of cycles and response)
  • Relapsed or refractory DLBCL after at least one prior systemic therapy, and prior to second- or third-line therapy for DLBCL (previous treatment can include ASCT)
  • Not planning to receive HD-ASCT at enrolment

Exclusion Criteria:

  • Concurrent participation in an interventional clinical study
  • Receiving ASCT therapy (note: having received ASCT in the past is not an exclusion criterion)
Contacts and Locations
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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): NCT04981795


Contacts
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Contact: Jeffrey Zhang +1 617-529-2655 Jeffrey.Zhang@morphosys.com
Contact: Aizza Hassan, MPH +1 857-289-1936 aizza.hassan@morphosys.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
MorphoSys AG
Iqvia Pty Ltd
Investigators
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Study Director: Mirko Vukcevic, PharmD, PhD MorphoSys AG
More Information
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Publications:

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Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT04981795    
Other Study ID Numbers: MOR208C414
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MorphoSys AG:
DLBCL
Lymphoma
Additional relevant MeSH terms:
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Lymphoma, Large B-Cell, Diffuse
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin