NCT06028828

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.

Detailed description

Eligible patients will receive an allogeneic stem cell transplantation using a combination of fludarabine, melphalan and total body irradiation (TBI) conditioning regimen and post-transplant high dose cyclophosphamide (PTCY), tacrolimus and mycophenolate mofetil (MMF) for graft-versus-host prophylaxis. Melphalan and TBI doses will be tailored based on the Hematopoietic Stem Cell Transplant- Composite Risk (HCT-CR), age and Karnofski performance status (KPS). Melphalan dose ranges from 100 -140 mg/m2 while TBI dose ranges from 2-5 Gy. All patients will be monitored for safety and efficacy up to 2 years post-transplantation.

Conditions

• Allogeneic Hematopoietic Stem Cell Transplantation
• Allogeneic Stem Cell Transplantation
• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	Fludarabine	Given Day-5, Day-4, Day-3, Day-2
DRUG	Melphalan	Given Day-5
RADIATION	Total Body Irradiation	Given Day-1

Timeline

• Start date: 2023-09-11
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2023-09-08
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study