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NCT03478514 · ClinicalTrials.gov registry record · Phase 2

Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma

A Phase 2 study of Mantle Cell Lymphoma and B-cell Lymphoma, sponsored by Alliance Foundation Trials.

Active
Registry status
Phase 2
Development phase
39
Enrollment target
9
Study locations

NCT03478514 is a Phase 2 study of Mantle Cell Lymphoma and B-cell Lymphoma that is active but no longer recruiting, run by Alliance Foundation Trials. The registered enrollment target is 39 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (62% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT03478514, a Phase 2 study of Mantle Cell Lymphoma and B-cell Lymphoma, is active but no longer recruiting, sponsored by Alliance Foundation Trials.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
39 participants
Enrollment target
9
Study locations

Study Summary

The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma to evaluate the efficacy of this combination, with the primary objective of the study being to assess median PFS and the secondary objectives to include ORR, CR, DOR, OS and toxicity. Subjects will be enrolled and treated with palbociclib and ibrutinib with each cycle of therapy being 28 days. Treatment will be based on the recommended phase II dose (RP2D) from the phase I combination trial.

Conditions Studied

Mantle Cell Lymphoma B-cell Lymphoma

Interventions

  • DRUG Palbociclib
  • DRUG Ibrutinib

Study Locations (9)

New York

  • Roswell Park Comprehensive Cancer Center - Buffalo
  • Weill Cornell Medical College - New York

California

  • City of Hope National Medical Center - Duarte

Maryland

  • University of Maryland, Greenebaum Comprehensive Cancer Center - Baltimore

Massachusetts

  • Massachusetts General Hospital - Boston

Michigan

  • St. Joseph Mercy Hospital Cancer Care Center - Ypsilanti

North Carolina

  • University of North Carolina - Chapel Hill

Ohio

  • Ohio State University - Columbus

South Carolina

  • Medical University of South Carolina - Hollings Cancer Center - Charleston

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2018-09-11
Est. Completion 2026-03-30
Phase Phase 2

Sponsor

Alliance Foundation Trials

20 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03478514

The ClinicalTrials.gov registry entry for NCT03478514 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (62% lower). The listed sponsor is Alliance Foundation Trials, which has 20 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Palbociclib is the first listed.

NCT03478514 reports 9 study locations spanning 8 distinct geographic areas - top geographies include New York, California, Maryland.

Frequently Asked Questions

What is clinical trial NCT03478514 about?

NCT03478514 is a clinical study titled "Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma". The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma to evaluate the efficacy of this combination, with the primary objective of the study being to assess median PFS and th...

What is the current status of trial NCT03478514?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2018-09-11. Estimated completion is 2026-03-30.

What conditions does trial NCT03478514 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma, B-cell Lymphoma.

What interventions are being tested in trial NCT03478514?

The interventions under investigation include: Palbociclib (DRUG), Ibrutinib (DRUG).

Who is sponsoring clinical trial NCT03478514?

This trial is sponsored by Alliance Foundation Trials, which has 20 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03478514 being conducted?

This trial has 9 study locations across California, Maryland, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.