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NCT02413489 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
A Phase 2 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT02413489: Clinical Trial Phase 2 study, sponsored by Janssen Research & Development.
NCT02413489 is a Phase 2 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02413489, a Phase 2 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), or Magnetic resonance imaging (MRI) scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a greater than (\>) 50 percent (%) decrease in the sum
Interventions
- DRUG Daratumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2015-09-02 |
| Est. Completion | 2017-06-01 |
| Phase | Phase 2 |
Why NCT02413489 stopped before completion
NCT02413489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Daratumumab is the first listed.
NCT02413489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02413489 about?
NCT02413489 is a clinical study titled "An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma". 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 le...
What is the current status of trial NCT02413489?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2015-09-02. Estimated completion is 2017-06-01.
What interventions are being tested in trial NCT02413489?
The interventions under investigation include: Daratumumab (DRUG).
Who is sponsoring clinical trial NCT02413489?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02413489's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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