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

N/ANot Yet RecruitingNCT06671717

Peking University People's Hospital25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsed Peripheral T-Cell Lymphoma Refractory Peripheral T-Cell Lymphoma

Interventions

Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell TransplantationOTHER

Drug: Pralatrexate, Chidamide 1. Pralatrexate: 30 mg/m2 intravenously (IV) administered weekly in 6-week cycles. Chidamide: 20mg, twice a week in 3-week cycles (2 weeks on treatment, 1 week off treatment) 2. After the 6-week therapy, the patients should receive PET/CT evaluation. 3. Patients would receive allo-HSCT if they could achieve at least PR after the first cycle of therapy. For the patients could not achieve a least PR after the first cycle of therapy, they should receive a second cycle of pralatrexate combined with chidamide. The interval between two cycles of pralatrexate combined with chidamide should be at least 1 week. 4. After the second cycle of 6-week therapy, the patients should receive PET/CT evaluation. Patients would receive allo-HSCT if they could achieve at least SD after the second cycle of therapy. For the patients could not achieve a least SD after the second cycle of therapy, they should receive other salvage therapies.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University, Institute of Hematolgoy, Beijing,

Beijing, China

Outcomes

Primary Outcomes

Progression-free survival (PFS) at 1 year after transplantation

The time from the end of transplantation to progression of disease or death at 1year

Time frame: Participants will be followed for an expected average of 1 years after transplantation

Central Contacts

Xiaodong Mo, MD

CONTACT

8610-8832-6001 mxd453@163.com

Xiaodong Mo, MD

CONTACT

8610-8832-4577 mxd453@163.com

Data from ClinicalTrials.gov

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