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

Summary

The purpose of this study is to assess overall response rate \[ORR, including complete response (CR) and partial response (PR)\], of daratumumab in participants with non-Hodgkin's lymphoma \[a cancer of the lymph nodes (or tissues)-NHL\] and 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 in participants with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.

Timeline

Start

2015-09-02

Primary completion

2017-06-01

Completion

2017-06-01

Outcome

Missed primary endpoint

Stopped (Enrollment): “DLBCL and FL cohorts met the pre-specified futility criteria and will not proceed. The MCL cohort was terminated due to slow recruitment and aggressive disease.”

paper Screen-fail rates were high, prespecified futility thresholds were met in 2 cohorts, and the study was terminated. PMID 30795996 ↗

Publications

• Salles G, Gopal AK, Minnema MC, Wakamiya K, Feng H, Schecter JM, Wang M. Phase 2 Study of Daratumumab in Relapsed/Refractory Mantle-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2019 May;19(5):275-284. doi: 10.1016/j.clml.2018.12.013. Epub 2019 Jan 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daratumumab	Monoclonal antibody	16 mg/kg	Intravenous

Indications