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

Peking University

Status

Not yet enrolling

Conditions

Refractory Peripheral T-Cell Lymphoma

Relapsed Peripheral T-Cell Lymphoma

Treatments

Other: Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT06671717

PUPH-PTCL-001

Details and patient eligibility

About

This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma

Enrollment

25 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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