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NCT02141451 · ClinicalTrials.gov registry record · Phase 1
ADAM17 Inhibitor/ Rituximab After Auto HCT for DLBCL
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02141451: Completed Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT02141451 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02141451, a Phase 1 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a single institution phase I/II study using an ADAM17 inhibitor (INCB7839) with rituximab as consolidation therapy after an autologous hematopoietic cell transplant (HCT) for patients with diffuse large B cell lymphoma (DLBCL). The study consists of two phases. The dose finding phase is a modified version of a phase I trial and the extended phase is a modified version of a phase II trial.
Primary Outcome
The Phase I design will continue until the MTD is declared or until the first dose is declared to be above MTD. Phase I dose limiting toxicity (DLT) is defined as Grade 3-5 non-hematologic, non-infectious toxicity including thromboembolic complications and select hematologic events including: grade 4 neutropenia lasting for ≥ 7 days, febrile neutropenia, grade 4 thrombocytopenia lasting ≥ 7 days despite dose delay or grade 3 thrombocytopenia associated with bleeding.
Interventions
- DRUG Rituximab
- DRUG INCB7839
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-05 |
| Est. Completion | 2019-06 |
| Phase | Phase 1 |
What the finished NCT02141451 record still lists
NCT02141451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT02141451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02141451 about?
NCT02141451 is a clinical study titled "ADAM17 Inhibitor/ Rituximab After Auto HCT for DLBCL". This is a single institution phase I/II study using an ADAM17 inhibitor (INCB7839) with rituximab as consolidation therapy after an autologous hematopoietic cell transplant (HCT) for patients with diffuse large B cell lymphoma (DLBCL). The study consists of two phases. The dose finding phase is a mo...
What is the current status of trial NCT02141451?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-05. Estimated completion is 2019-06.
What interventions are being tested in trial NCT02141451?
The interventions under investigation include: Rituximab (DRUG), INCB7839 (DRUG).
Who is sponsoring clinical trial NCT02141451?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02141451's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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