An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

Update Il y a 4 ans
Reference: EUCTR2014-005299-26

Woman and Man

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Extract

The study will evaluate daratumumab separately in three relapsed or refractory NHL subtypes that are CD38 positive: MCL, DLBCL, and FL. There are two main objectives: -To assess overall response rate (ORR, including complete response (CR) and partial response (PR)), of daratumumab in subjects with CD38+ disease in each NHL subtype. -To evaluate association between ORR and CD38 expression level in order to determine a threshold for CD38 expression level in each NHL subtype, above which daratumumab activity is enhanced.


Inclusion criteria

  • Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma