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NCT03323151 · ClinicalTrials.gov registry record · Phase 1
A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma
A Phase 1 study, sponsored by PrECOG.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT03323151: Completed Phase 1 study, sponsored by PrECOG.
NCT03323151 is a Phase 1 study that has completed, run by PrECOG. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03323151, a Phase 1 study, has completed, sponsored by PrECOG.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory (progressed on treatment) will receive ixazomib and ibrutinib. Ibrutinib has been approved by the Food and Drug Administration (FDA) as treatment for patients with mantle cell lymphoma who have received at least one prior therapy. Ixazomib is in a class of medications called proteasome inhibitors. Cancer cells depend on proteasome to provide this protein metabolism (turnover) function to regulate their growth and survival. Ixazomib disrupts a cancer cells' ability to survive by blocking the proteasome and disrupting protein metabolism. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether the addition of ixazomib to ibrutinib chemotherapy is effective in treating people who have relapsed or refractory MCL and to examine the side effects associated with ixazomib in combination with ibrutinib.
Primary Outcome
To determine the maximum tolerable dose (MTD) of ixazomib (mg) in combination with ibrutinib (mg) in patients with relapsed/refractory mantle cell lymphoma (MCL) using DLT endpoint.
Interventions
- DRUG Ibrutinib
- DRUG Ixazomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-08-13 |
| Est. Completion | 2023-09-07 |
| Phase | Phase 1 |
What the finished NCT03323151 record still lists
NCT03323151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibrutinib is the first listed.
NCT03323151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03323151 about?
NCT03323151 is a clinical study titled "A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma". Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory (progressed on treatment) will receive ixazomib and ibrutinib. Ibrutinib has been approved by the Food and Drug Administration (FDA) as treatment for patients with mantle cell lymphoma who have received at least on...
What is the current status of trial NCT03323151?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2018-08-13. Estimated completion is 2023-09-07.
What interventions are being tested in trial NCT03323151?
The interventions under investigation include: Ibrutinib (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT03323151?
This trial is sponsored by PrECOG, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03323151's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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