Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of Pemigatinib in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
This phase II trial tests how well pemigatinib works in treating patients with mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Pemigatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To evaluate the efficacy of pemigatinib in patients with relapsed or refractory (R/R) MCL. II. To evaluate the efficacy of pemigatinib in patients with R/R MZL. SECONDARY OBJECTIVES: I. To evaluate the complete response (CR) rate at end of cycle 6 (C6). II. To evaluate the duration of response (DOR). III. To evaluate the median and 2-year progression-free survival (PFS). IV. To evaluate the median and 2-year overall survival (OS). EXPLORATORY OBJECTIVE: I. To evaluate the factors predictive of response to pemigatinib and identify mechanism of resistance to therapy. OUTLINE: Patients receive pemigatinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also under computed tomography (CT) and positron emission tomography (PET) or PET/CT and blood sample collection at screening and on study. Patients may also undergo bone marrow aspirate and biopsy during screening and on study. After completion of study treatment, patients are followed up at 30 days and then every 3 or 6 months. ;
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|---|---|---|---|
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