BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)

PHASE2RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

January 27, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Acute LeukemiaMDS
Interventions
DEVICE

Arm1

Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2

DRUG

Arm1

"All patients will receive the following standard conditioning regimen:~Fludarabine 30 mg/m2 IVPB daily from Day -6 (6 days before stem cell infusion) through Day -2"

DRUG

Arm1

IV cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5.

DEVICE

Arm 1

Total body irradiation 2Gy on day -1.

OTHER

Arm1

Stem cell infusion on day 0.

DRUG

Arm1

Tacrolimus IV initially in doses of 0.15 mg/kg/day for 3 days, followed by conversion to oral therapy (0.15 mg/kg twice daily)

DRUG

Arm1

Cyclophosphamide on days 3 and 4 after transplant at a dose of 50mg/kg per day

Trial Locations (1)

60612

RECRUITING

University of Illinois Cancer Center, Chicago

All Listed Sponsors
lead

University of Illinois at Chicago

OTHER