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

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02413489
Phase
PHASE2
Status
Terminated

Conditions

  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab 16 mg/kg will be administered as intravenous infusion to participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

Study Details

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.

Key Dates

Start date
Sep 2, 2015
Status verified
Jan 2025
Primary completion
Jun 1, 2017
Completion
Jun 1, 2017

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab
    Participants will receive daratumumab (16 milligram per kilogram \[mg/kg\]) as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: After the first dose until disease progression, withdrawal of consent from study participation, or the end of study (approximately 1.9 years) ]

Locations (14)

FacilityCityStateZIPSite coordinators
-DuarteCalifornia--
-Fountain ValleyCalifornia--
-JacksonvilleFlorida--
-Pembroke PinesFlorida--
-AtlantaGeorgia--
-ChicagoIllinois--
-LouisvilleKentucky--
-BaltimoreMaryland--
-RochesterMinnesota--
-OmahaNebraska--
-New BrunswickNew Jersey--
-PittsburghPennsylvania--
-HoustonTexas--
-SeattleWashington--

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