Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anaplastic Large Cell Lymphoma
- Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
- Recurrent Anaplastic Large Cell Lymphoma
- Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Recurrent Angioimmunoblastic T-Cell Lymphoma
- Refractory Mycosis Fungoides
- Recurrent Enteropathy-Associated T-Cell Lymphoma
- Recurrent Follicular Lymphoma
- Recurrent Hepatosplenic T-Cell Lymphoma
- Recurrent Mature T- Cell and NK-Cell Non-Hodgkin Lymphoma
- Refractory Anaplastic Large Cell Lymphoma
- Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
- Refractory Hepatosplenic T-Cell Lymphoma
- Refractory Enteropathy-Associated T-Cell Lymphoma
- Recurrent Monomorphic Epitheliotropic Intestinal T-cell Lymphoma
- Refractory Follicular Lymphoma
- Recurrent Mycosis Fungoides
- Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified
- Refractory Angioimmunoblastic T-Cell Lymphoma
- Subcutaneous Panniculitis Like T Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of a regimen combining pembrolizumab and pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). II. Establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combined pralatrexat...
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of a regimen combining pembrolizumab and pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). II. Establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combined pralatrexate and pembrolizumab regimen. III. Estimate the overall response rate (ORR) according to the Lugano Classification in patients treated with pembrolizumab plus pralatrexate at the RP2D. SECONDARY OBJECTIVES: I. Estimate the complete response (CR) rate according to the Lugano Classification duration of response (DOR), overall survival (OS) and progression-free survival (PFS) in patients treated with pembrolizumab plus pralatrexate. II. Estimate the ORR and CR rate according to the International Harmonization Project response criteria. III. Evaluate responses and disease progression according to the Lymphoma Response to Immunomodulatory therapy Criteria (LYRIC). EXPLORATORY OBJECTIVE: I. Explore immunologic and genomic biomarkers of response to pembrolizumab plus pralatrexate therapy. OUTLINE: This is a phase I, dose-escalation study of pralatrexate followed by a phase II study. Patients receive pralatrexate intravenously (IV) over 3-5 minutes on days 1 and 8 and pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 and 90 days, every 12 weeks for 1 year, and then every 18 weeks thereafter.
Tracking Information
- NCT #
- NCT03598998
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Alex F Herrera City of Hope Medical Center
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