Clinical Trials Logo

Clinical Trial Summary

This phase I/II trial studies the side effects and best dose of pralatrexate when given together with pembrolizumab and how well they work in treating patients with peripheral T-cell lymphomas that has come back after a period of improvement or has not responded to treatment. Pralatrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and pralatrexate may work better in treating patients with peripheral T-cell lymphomas.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms

  • Anaplastic Large Cell Lymphoma
  • Enteropathy-Associated T-Cell Lymphoma
  • Intestinal Diseases
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Mycoses
  • Mycosis Fungoides
  • Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
  • Panniculitis
  • Recurrence
  • Recurrent Anaplastic Large Cell Lymphoma
  • Recurrent Angioimmunoblastic T-Cell Lymphoma
  • Recurrent Enteropathy-Associated T-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Hepatosplenic T-Cell Lymphoma
  • Recurrent Mature T- Cell and NK-Cell Non-Hodgkin Lymphoma
  • Recurrent Monomorphic Epitheliotropic Intestinal T-cell Lymphoma
  • Recurrent Mycosis Fungoides
  • Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Refractory Anaplastic Large Cell Lymphoma
  • Refractory Angioimmunoblastic T-Cell Lymphoma
  • Refractory Enteropathy-Associated T-Cell Lymphoma
  • Refractory Follicular Lymphoma
  • Refractory Hepatosplenic T-Cell Lymphoma
  • Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Refractory Mycosis Fungoides
  • Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Subcutaneous Panniculitis-Like T-Cell Lymphoma

NCT number NCT03598998
Study type Interventional
Source City of Hope Medical Center
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date February 4, 2019
Completion date June 29, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Completed NCT02168140 - CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma Phase 1
Completed NCT01943682 - Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma Phase 1
Completed NCT01427881 - Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies Phase 2
Completed NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Completed NCT00003196 - Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma N/A
Terminated NCT01678443 - Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies Phase 1
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Terminated NCT03947255 - A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma Phase 2
Terminated NCT01408043 - Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma N/A
Completed NCT01466881 - Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma Phase 2
Completed NCT00608361 - Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery Phase 1
Completed NCT00131937 - Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma Phase 2
Completed NCT00278382 - Sorafenib in Treating Patients With Recurrent Non-Hodgkin's Lymphoma Phase 2
Completed NCT00098891 - MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00004241 - 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma Phase 1
Recruiting NCT05377827 - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies Phase 1
Completed NCT01254578 - Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers Phase 1
Recruiting NCT03443128 - Vinorelbine for Recurrent ALCL-2017 Phase 2
Completed NCT03397953 - Vinorelbine for Recurrent ACLC Phase 2