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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

September 18, 2019

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Hematologic Malignancies
Interventions
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.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER