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Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma

NCT03478514 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-04-09

No results posted yet for this 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

Interventions

DRUG

Palbociclib

Taken at 100 mg once daily for 21 days, followed by 7 days off

DRUG

Ibrutinib

560 mg taken orally all patients throughout the study

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Alliance Foundation Trials, LLC.

    lead OTHER

Principal Investigators

  • Evanthia Galanis, MD · Alliance Foundation Trials, LLC.

  • Kami Maddocks, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2025-11-10
Completion
2026-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478514 on ClinicalTrials.gov