NCT06671717

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-04-01
• Completion: 2027-07-01
• First posted: 2024-11-04
• Last updated: 2024-11-06

Locations

1 site across 1 country: China