Diffuse Large B-Cell Lymphoma: Tafasitamab Plus Lenalidomide in Addition to R-CHOP

Summary

This study focuses on individuals who have been recently diagnosed with diffuse large B-cell lymphoma (DLBCL), a cancer of the blood system. Most patients with newly diagnosed DLBCL are treated with the standard therapy called R-CHOP, which consists of several medicines including chemotherapy and the monoclonal antibody rituximab. The purpose of this study is to determine whether addition of the study drugs (tafasitamab plus lenalidomide) to R-CHOP is more effective and safe compared with R-CHOP treatment alone in newly diagnosed, previously untreated patients with higher-risk DLBCL. Tafasitamab is a monoclonal antibody that targets lymphoma cells and may help the immune system to destroy cancer cells. Lenalidomide is a drug that affects the immune system and promotes immune responses to help slow tumor growth. The use of tafasitamab and lenalidomide is investigational in this study because the drugs have not yet been approved by the U.S. Food and Drug Administration to treat previously untreated patients with DLBCL. Participants will be randomly assigned to receive either tafasitamab in combination with lenalidomide, or placebo (inactive substance) in combination with standard RCHOP treatment.


Inclusion Criteria

  • Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible:
  • DLBCL, NOS including GCB type, ABC type
  • T-cell rich large BCL
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Study Location(s)

  • Cedars-Sinai Cancer at Beverly Hills (THO)
  • Cedars-Sinai Cancer at SOCC
  • Cedars-Sinai Cancer at The Angeles Clinic and Research Institute


More about this Clinical Trial

Full Title

MOR208C310: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly diagnosed diffuse large B-cell lymphoma [frontMIND]

Details
Disease Type/Condition

Non-Hodgkin's Lymphoma

Principal Investigator

Darrah, Justin

Co-Investigators

Akil Merchant, Andrew Horodner, David Hoffman, Hugo Hool, Jeremy Lorber, Kevin Scher, Noah Merin, Robert Vescio, Ronald Paquette, Sepehr Rokhsar, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey

Age Group

Adult

Phase

III

IRB Number

STUDY00001904

ClinicalTrials.gov ID

NCT04824092

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Non-Hodgkin's Lymphoma

Principal Investigator

Darrah, Justin

Age Group

Adult

Phase

III

IRB Number

MOR208C310

ClinicalTrials.gov ID

NCT04824092

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?