NCT04098393

Giving Chemotherapy for a Shortened Amount of Time Before a Stem Cell Transplantation

A Pilot Study of Condensed Busulfan, Melphalan, and Fludarabine Conditioning Prior to Ex-vivo CD34+ Selected Allogeneic Hematopoietic Cell Transplantation

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if a condensed version of the chemotherapy regimen busulfan, melphalan, fludarabine (bu/mel/flu) and the drug antithymocyte globulin (ATG-also referred to as rATG or thymoglobulin) can have the same or fewer number of severe side effects in people with various blood cancers 30 days after they receive an allogeneic hematopoietic cell transplantation.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	Busulfan 3.2 mg/kg/day	Busulfan 3.2 mg/kg/day, with dose adjustments made according to pharmacokinetic (PK) levels.
DRUG	Fludarabine	Fludarabine (25mg/m2/ day) administered on days -6, -5, -4, -3, and -2.
DRUG	Melphalan	Melphalan (70mg/m2/day) administered on days -6 and -5.
DRUG	Antithymocyte globulin (ATG)	ATG will be given based on a dynamic nomogram based on the patient's absolute lymphocyte count at the start of conditioning and can result in 2 or 3 days of ATG administration.
DRUG	Busulfan 0.8 mg/kg	Busulfan 0.8 mg/kg every 6 hours x 10 doses, with dose adjustments made according to PK levels.
PROCEDURE	Allogeneic hematopoietic cell transplantation (Allo-HCT)	Allogeneic hematopoietic cell transplantation following the conditioning regimen.

Timeline

• Start date: 2019-09-18
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2019-09-23
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study