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

NCT ID: NCT06671717

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2027-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Wuhan TongJi Hospital

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao-Jun Huang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaodong Mo

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University, Institute of Hematolgoy, Beijing,

Beijing, , China

Countries

China

Central Contacts

Xiaodong Mo, MD

Role: CONTACT

mxd453@163.com

8610-8832-6001

Xiaodong Mo, MD

Role: CONTACT

mxd453@163.com

8610-8832-4577

Facility Contacts

Xiaodong Mo

Role: primary

Other Identifiers

PUPH-PTCL-001

Identifier Type: -

Identifier Source: org_study_id