Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma (NCT02159755) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma
United States28 participantsStarted 2014-08-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed mantle cell lymphoma as defined by the World Health Organization; all patients must have either t(11;14) by karyotype or fluorescent in-situ hybridization (FISH) or positive immunohistochemistry for cyclin D1
* Subjects must have measurable disease defined as at least one tumor lesion of at least 1.5 cm or a peripheral blood CD5+, CD19+ lymphocyte count of at least 5,000 cells/uL
* Subjects must have received at least one prior treatment regimen
* Subjects that have received a prior BTK inhibitor or CDK4/6 inhibition are ineligible
* Subjects that have undergone prior allogeneic stem cell transplantation will only be eligible if the transplant occurred at least 1 year prior to study entry, the patient is no longer taking any immunosuppressive therapy, and there are no significant ongoing transplant-related adverse effects
* Subjects must not have received chemotherapy =\< 21 days prior to first administration of study treatment, monoclonal antibody =\< 6 weeks prior to first administration of study treatment, and/or radiotherapy or other investigational agents =\< 4 weeks prior to first administration study treatment unless the subjects' tumor has progressed on the previous therapy and the investigator believes that the patient should not postpone further therapy and, all treatment-related toxicities have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 =…
What they're measuring
1
Recommended phase II dose of the combination of ibrutinib and palbociclib