Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

April 24, 2017

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Acute Myeloid LeukemiaMyelodysplastic Syndromes
Interventions
DRUG

Fludarabine

40 mg/m\^2 IVBP daily for day -5 (5 days before stem cell infusion) through Day -2

DRUG

Busulfan

targeting a 4800μM/min/ day from day -5 through day -2

DRUG

ATG

0.5 mg/kg IV on day -3, and 2 mg/kg on days -2 and day -1

RADIATION

Total Marrow Irradiation

dose of 3Gy on days -3, -2 and -1

PROCEDURE

Stem Cell Product Infusion

Day 0 according to BMT unit policy

DRUG

Tacrolimus

The starting dose is at 0.03 mg/kg/day IV continuous infusion over 24 hr from 4 PM on day -2. Dose will be adjusted to target trough levels of 5-15 ng/mL. More information is available in the protocol document.

DRUG

Methotrexate

5mg/m\^2 on Day 1, 5 mg/m\^2 on Days 3, 6 and 11

Trial Locations (1)

60612

University of Illinois at Chicago, Chicago

All Listed Sponsors
lead

University of Illinois at Chicago

OTHER