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
|Condition or disease|
|Diffuse Large B-cell Lymphoma|
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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
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.
- 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,
- 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
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
|Contact: Jeffrey Zhang||+1 617-529-2655||Jeffrey.Zhang@morphosys.com|
|Contact: Aizza Hassan, MPH||+1 email@example.com|
|Study Director:||Mirko Vukcevic, PharmD, PhD||MorphoSys AG|