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NCT03235544 · ClinicalTrials.gov registry record · Phase 2
A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
A Phase 2 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
NCT03235544: Completed Phase 2 study, sponsored by Incyte Corporation.
NCT03235544 is a Phase 2 study that has completed, run by Incyte Corporation. The registered enrollment target is 162 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03235544, a Phase 2 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 162 participants
- Enrollment target
Study Summary
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
Primary Outcome
ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Cr
Interventions
- DRUG Parsaclisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2017-11-20 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 2 |
What the finished NCT03235544 record still lists
NCT03235544 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 1 intervention - of which Parsaclisib is the first listed.
NCT03235544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03235544 about?
NCT03235544 is a clinical study titled "A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor". This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
What is the current status of trial NCT03235544?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2017-11-20. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT03235544?
The interventions under investigation include: Parsaclisib (DRUG).
Who is sponsoring clinical trial NCT03235544?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03235544's enrollment target sits among peer trials
162 418th of 2000 higher than 1,579 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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