NCT04118075

PT-CY With or Without Low-dose ATG for Lymphoid Malignancies Undergoing Allo-HSCT

Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

All patients received Flu-BU-VP16 as myeloablative conditioning followed by cyclophosphamide (D+3 and +4) and subsequent tacrolimus. For patients with unrelated or haplo-donor received low-dose ATG at Day +15.

Detailed description

For patients with high-risk lymphoid malignancies, patients will undergo allo-HSCT from HLA matched sibling, unrelated (9\~10/10) donor or hallo-identical donors. For all patients will receive myeloablative conditioning with 5-day fludarabine, 2-day VP-16 and 3-day busulifan. For prophylaxis graft versus host disease (GVHD), patients will receive cyclophosphamide 50mg/kg daily on D+3 and +4 with subsequent tacrolimus starting at D+5. For patients receiving HSCT from unrelated or haplo-donor, low-dose ATG 2.5mg/kg will be given on Day +15.

Conditions

• GVHD, Acute

Interventions

Type	Name	Description
DRUG	PT-CY-FK +/-ATG	GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2019-10-08
• Last updated: 2021-05-21

Locations

1 site across 1 country: China