Pralatrexate Combined With Chidamide Bridging Allogeneic HSCT for Refractory/Relapsed Peripheral T-cell Lymphoma

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a type of cancer called Peripheral T-cell Lymphoma, particularly those whose cancer has come back or did not respond to previous treatments. The researchers want to see how well a combination of two drugs, Pralatrexate and Chidamide, can help patients prepare for a procedure known as Allogeneic Hematopoietic Stem Cell Transplantation, which is a treatment that can help restore healthy blood cells in the body.

To be eligible for this trial, participants need to be adults aged 65 to 74 years who have been diagnosed with Peripheral T-cell Lymphoma and have at least one measurable tumor. They should also be in fairly good health, meaning they can perform daily activities without too much difficulty. If someone joins the trial, they can expect to receive the study drugs and be monitored closely to see how their condition responds. It’s important to note that patients who have certain other types of lymphoma, serious organ problems, or a history of specific diseases may not be able to participate. This trial is not yet recruiting, so patients interested in joining should watch for updates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients fully understand the study, voluntarily participate in and sign on the informed consent;
• • Diagnosed by histopathology Peripheral T-cell lymphoma;
• • ECOG PS score 0 or 1;
• • Relapsed or Refractory Peripheral T Cell Lymphoma；
• • According to the 2014 version of the Lugano criteria for lymphoma, there must be at least one CT/MRI measurable lesion (measurable lymph node diameter\>1.5cm; measurable extranodal lesion diameter\>1.0cm)；
• • Provided a written pathological/histological diagnosis report during the screening period and agreed to provide tumor tissue sections or tumor/lymph node tissue specimens for testing at the central laboratory;
• • Expected survival at least 12 weeks；
• • Agreed to receive treatment with Pralatrexate
• Exclusion Criteria:
• • NK/T-cell lymphoma;
• • Achieving CR or PR after induction chemotherapies without relapse;
• • Dysfunction of vital organs;
• • Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation;
• • Unwilling to accept allogeneic hematopoietic stem cell transplantation;
• • Undergoing other clinical studies within a month;
• • Without donor for transplantation;
• • Allergies to similar drugs and excipients of the research drug