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

NCT06671717 | Not Yet Recruiting

• 1 other identifier: PUPH-PTCL-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Allogeneic hematopoietic stem cell transplantation; Pralatrexate; Remission status before transplantation

Outcome Measures

Primary Outcomes (1)

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

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

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

Study Arms (1)

Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients

EXPERIMENTAL

Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients

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

Interventions

Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation OTHER

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.

Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Ruijin Hospital: collaborator
• Wuhan TongJi Hospital: collaborator
• West China Hospital: collaborator

Study Sites (1)

Peking University, Institute of Hematolgoy, Beijing,

Beijing, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Xiaodong Mo

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodong Mo, MD

CONTACT

8610-8832-6001; mxd453@163.com

Xiaodong Mo, MD

CONTACT

8610-8832-4577; mxd453@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

CN (1)