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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 is a Phase 1 study that has completed, run by PrECOG. The registered enrollment target is 43 participants.

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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.

Interventions

  • DRUG Ibrutinib
  • DRUG Ixazomib

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2018-08-13
Est. Completion 2023-09-07
Phase Phase 1

Sponsor

PrECOG

17 total trials

What the Registry Record Tells You About NCT03323151

The ClinicalTrials.gov registry entry for NCT03323151 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PrECOG, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ibrutinib is the first listed.

NCT03323151 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.