Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
Alliance Foundation Trials, LLC.
Study ID
NCT03478514
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • B Cell Lymphoma
  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palbociclib — DRUG
    Taken at 100 mg once daily for 21 days, followed by 7 days off
  • Ibrutinib — DRUG
    560 mg taken orally all patients throughout the study

Study Details

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.

Key Dates

Start date
Sep 11, 2018
Status verified
Sep 2025
Primary completion
Nov 10, 2025
Completion
Aug 30, 2026

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    All patients will receive palbociclib at 100 mg oral once a day for 21 days, followed by 7 days off. Ibrutinib will be administered at 560 mg oral continuously.

Primary Outcome Measure

Progression free survival [ Time Frame: 42 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
University of Maryland, Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Massachusetts General HospitalBostonMassachusetts02114-
St. Joseph Mercy Hospital Cancer Care CenterYpsilantiMichigan48197-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Weill Cornell Medical CollegeNew YorkNew York10065-
University of North CarolinaChapel HillNorth Carolina27599-
Ohio State UniversityColumbusOhio43210-
Medical University of South Carolina - Hollings Cancer CenterCharlestonSouth Carolina29425-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAUniversity of Maryland, Greenebaum Comprehensive Cancer Center· Baltimore, MDMassachusetts General Hospital· Boston, MASt. Joseph Mercy Hospital Cancer Care Center· Ypsilanti, MIRoswell Park Comprehensive Cancer Center· Buffalo, NYWeill Cornell Medical College· New York, NY

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