Pembrolizumab and Pralatrexate in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03598998|
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma Recurrent Mycosis Fungoides Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Refractory Mycosis Fungoides||Biological: Pembrolizumab Drug: Pralatrexate||Phase 1 Phase 2|
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.
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).
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.
Participants 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, participants are followed up at 30 and 90 days, every 12 weeks for 1 year, and then every 18 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of Pembrolizumab Plus Pralatrexate for Treatment of Relapsed or Refractory Peripheral T-Cell Lymphomas|
|Actual Study Start Date :||February 4, 2019|
|Estimated Primary Completion Date :||April 27, 2021|
|Estimated Study Completion Date :||April 27, 2021|
Experimental: Treatment (pralatrexate and pembrolizumab)
Participants receive pralatrexate 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.
- Maximum tolerated dose defined as the highest doe level at which < 2 out of 6 evaluable subjects experienced dose limiting toxicities (Phase I) [ Time Frame: Up to 21 days ]Toxicities will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Overall response rate (ORR) according to Lugano classification (Phase II) [ Time Frame: Up to 48 months ]
- Complete response (CR) rate according to Lugano classification [ Time Frame: Up to 48 months ]
- ORR according to the International Harmonization Project response criteria [ Time Frame: Up to 48 months ]
- CR rate according to the International Harmonization Project response criteria [ Time Frame: Up to 48 months ]
- Duration of response (DOR) based on Lymphoma Response to Immunomodulatory therapy Criteria (LYRIC) criteria [ Time Frame: Up to 48 months ]
- Overall survival (OS) [ Time Frame: From initiation of study therapy to death from any cause, assessed up to 48 months ]
- Progression-free survival (PFS) [ Time Frame: From initiation of study therapy to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 48 months ]
- Incidence of adverse events assessed by NCI CTCAE version (v)5.0 [ Time Frame: Up to 90 days after last dose ]Observed toxicities will be summarized by type (organ affected or laboratory determination such as absolute neutrophil count, severity (by NCI CTCAE v5.0 and nadir or maximum values for lab measures), date of onset, duration, reversibility, and attribution.
- Incidence of unacceptable toxicity assessed by NCI CTCAE version 5.0 [ Time Frame: Up to 90 days after last dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598998
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Alex F. Herrera, MD 626-256-4673 ext 62405 firstname.lastname@example.org|
|Principal Investigator: Alex F. Herrera, MD|
|United States, Nebraska|
|University of Nebraska Medical Center||Not yet recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Matthew A. Lunning, MD 402-559-3848 email@example.com|
|Principal Investigator: Matthew A. Lunning, MD|
|United States, New Jersey|
|Hackensack University Medical Center||Not yet recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: Tatyana A. Feldman, MD 551-996-4469 Tatyana.Feldman@Hackensackmeridian.org|
|Principal Investigator: Tatyana A. Feldman, MD|
|Principal Investigator:||Alex Herrera, MD||City of Hope Medical Center|