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NCT02158975 · ClinicalTrials.gov registry record · Phase 2
Open-label, Phase II Study of MLN9708 in Patients With Relapsed/Refractory Cutaneous and Peripheral T-cell Lymphomas
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT02158975: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT02158975 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02158975, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
Historically cutaneous and peripheral T-cell lymphomas have response rates of approximately 30% to standard chemotherapy regimens. We alternatively hypothesize that MLN9708 will be active in this disease and will improve best objective response. We will also determine the extent to which MLN9708 inhibits GATA-3 (Trans-acting T-cell-specific transcription factor) expression, which is associated with poor prognosis, and whether GATA-3 expression represents a novel predictive biomarker for MLN9708 sensitivity.
Primary Outcome
The percentage of patients with an objective response rate will be determined. The overall response will be based on response in each compartment (skin, blood, lymph nodes and viscera) using a global composite scoring system. Objective response is considered (CR) Complete Response (Complete disappearance of all clinical evidence of disease), CRu (Complete Response Unconfirmed), or (PR) Partial Response (Regression of measurable disease).
Interventions
- DRUG MLN9708
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
What the finished NCT02158975 record still lists
NCT02158975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which MLN9708 is the first listed.
NCT02158975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02158975 about?
NCT02158975 is a clinical study titled "Open-label, Phase II Study of MLN9708 in Patients With Relapsed/Refractory Cutaneous and Peripheral T-cell Lymphomas". Historically cutaneous and peripheral T-cell lymphomas have response rates of approximately 30% to standard chemotherapy regimens. We alternatively hypothesize that MLN9708 will be active in this disease and will improve best objective response. We will also determine the extent to which MLN9708 in...
What is the current status of trial NCT02158975?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2014-09. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02158975?
The interventions under investigation include: MLN9708 (DRUG).
Who is sponsoring clinical trial NCT02158975?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02158975's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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