Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02159755
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Recurrent Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Palbociclib — DRUG
    Given PO
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of ibrutinib and palbociclib in treating patients with previously treated mantle cell lymphoma. Ibrutinib and palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Palbociclib may also help ibrutinib work better by making cancer cells more sensitive to the drug.

Key Dates

Start date
Aug 13, 2014
Status verified
May 2026
Primary completion
Jun 25, 2018
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: Treatment (ibrutinib, palbociclib)
    Patients receive ibrutinib PO QD on days 1-28 and palbociclib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Recommended phase II dose of the combination of ibrutinib and palbociclib [ Time Frame: Up to 28 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in St Louis, MO

By research site
Washington University School of Medicine· St Louis, MONYP/Weill Cornell Medical Center· New York, NYUNC Lineberger Comprehensive Cancer Center· Chapel Hill, NCOhio State University Comprehensive Cancer Center· Columbus, OH

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