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NCT Number: NCT06671717

Pralatrexate Combined With Chidamide Bridging Allogeneic HSCT 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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University, Institute of Hematolgoy, Beijing,

Beijing, China

Location contact

Xiaodong Mo

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation

Other

Drug: Pralatrexate, Chidamide

  • 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)
  • After the 6-week therapy, the patients should receive PET/CT evaluation.
  • 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.
  • 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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodong Mo, MD

CONTACT

[email protected]

8610-8832-6001

Xiaodong Mo, MD

CONTACT

[email protected]

8610-8832-4577

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Ruijin Hospital
  • West China Hospital
  • Wuhan TongJi Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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