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NCT02681302 · ClinicalTrials.gov registry record · Phase 1
Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence
A Phase 1 study, sponsored by Hackensack Meridian Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT02681302: Clinical Trial Phase 1 study, sponsored by Hackensack Meridian Health.
NCT02681302 is a Phase 1 study that was terminated before completion, run by Hackensack Meridian Health. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02681302, a Phase 1 study, was terminated before completion, sponsored by Hackensack Meridian Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
The goal of this study is to determine the safety and clinical effect of combined checkpoint inhibition administered after autologous hematopoietic stem cell transplantation in each of six clinical cohorts of high risk and recurrent disease. In addition to assessing the incidence and severity of adverse events and rates of complete response and progression free survival, investigators intend to monitor immune reconstitution, phenotype and TCR repertoire throughout treatment and at the time of disease progression. Investigators will also analyze the gut microbiome prior to conditioning, throughout treatment, post-transplant and at time of relapse.
Primary Outcome
To assess the safety of combined check point inhibition with nivolumab and ipilimumab after autologous hematopoietic stem cell transplantation in patients at high risk for post-transplant recurrence including patients with persistent and recurrent high risk diffuse large B cell lymphoma, high risk and recurrent T cell lymphoma and high risk and recurrent multiple myeloma. The composite endpoint consisting of the occurrence of at least one treatment-related limiting toxicity (after combined check
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2016-06-07 |
| Est. Completion | 2024-05-10 |
| Phase | Phase 1 |
Why NCT02681302 stopped before completion
NCT02681302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT02681302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02681302 about?
NCT02681302 is a clinical study titled "Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence". The goal of this study is to determine the safety and clinical effect of combined checkpoint inhibition administered after autologous hematopoietic stem cell transplantation in each of six clinical cohorts of high risk and recurrent disease. In addition to assessing the incidence and severity of adv...
What is the current status of trial NCT02681302?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2016-06-07. Estimated completion is 2024-05-10.
What interventions are being tested in trial NCT02681302?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT02681302?
This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02681302's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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