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

November 4, 2024 updated by: Xiao-Jun Huang, Peking University People's Hospital

Pralatrexate Combined With Chidamide Bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaodong Mo, MD
  • Phone Number: 8610-8832-6001
  • Email: mxd453@163.com

Study Contact Backup

  • Name: Xiaodong Mo, MD
  • Phone Number: 8610-8832-4577
  • Email: mxd453@163.com

Study Locations

  • China
      • Beijing, China
        • Peking University, Institute of Hematolgoy, Beijing,
        • Contact:
          • Xiaodong Mo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients
Other: Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) at 1 year after transplantation
Time Frame: 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
Participants will be followed for an expected average of 1 years after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

West China Hospital
Ruijin Hospital
Wuhan TongJi Hospital

Investigators

  • Principal Investigator: Xiaodong Mo, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 1, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUPH-PTCL-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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