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

Not Applicable

Not yet recruiting

• Conditions: Relapsed Peripheral T-Cell Lymphoma; Refractory Peripheral T-Cell Lymphoma

• Registration Number: NCT06671717
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Study Start: 2024-12
• Primary Completion: 2027-04
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) at 1 year after transplantation	Participants will be followed for an expected average of 1 years after transplantation	The time from the end of transplantation to progression of disease or death at 1year

Trial Locations

Locations (1)

Peking University, Institute of Hematolgoy, Beijing,; 🇨🇳 Beijing, China