NCT07091006

Efficacy and Safety of VAH as a Bridging Regimen to Allo-HCT in Relapsed/Refractory AML

A Prospective Study on the Efficacy and Safety of Venetoclax, Azacitidine, and Homoharringtonine (VAH) Combination as a Bridging Regimen to Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed/Refractory Acute Myeloid Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Allogeneic hematopoietic cell transplantation (allo-HCT) is the only treatment that offers a possible cure for relapsed/refractory AML. Currently, the optimal preallo-HCT bridging regimen for relapsed/refractory AML patients is unclear. Venetoclax-based regimens, including Venetoclax + demethylating agents (HMA) , Venetoclax + HMA + other drugs and Venetoclax-based multidrug combinations as a bridging regimen improves response rate and post-transplant survival in relapsed/refractory AML patients. Therefore, the investigators conduct a prospective single-centre clinical study to evaluate the efficacy and safety of VAH as a transplant bridging regimen for relapsed/refractory AML.

Detailed description

Relapsed/refractory acute myeloid leukaemia has an extremely poor prognosis, and allogeneic haematopoietic stem cell transplantation is the only treatment that offers the possibility of a cure for relapsed/refractory AML. Currently, the optimal pre-allo-HCT bridging regimen for relapsed/refractory AML patients is unclear. Previous studies have found that venetoclax and Azacitidine combined with homoharringtonine (VAH) bridging allogeneic transplantation for relapsed/refractory AML has a post-transplantation CRc of 78% and a 1-year OS of 85%, which is superior to other bridging regimens, and we have also found that VAH has a better safety and efficacy as a pre-transplantation bridging in our previous study. Therefore, the investigators propose to conduct a prospective single-centre clinical study to evaluate the efficacy and safety of VAH as a bridging regimen for transplantation in relapsed/refractory AML. The aim of the study is assessment of the efficacy and safety of allogeneic haematopoietic stem cell transplantation for relapsed/refractory acute myeloid leukaemia in combination with venetoclax and Azacitidine in combination with homoharringtonine.

Conditions

• Relapse Leukemia

Interventions

Type	Name	Description
DRUG	VAH	For R/R AML patients, VAH bridging to conditioning regimen for allo-HCT.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: China