Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)

ConditionsAcute Myeloid Leukemia, Relapsed, Adult Acute Myeloid Leukemia Refractory Chronic Myeloid Leukemia - Accelerated Phase Myelodysplastic Syndromes

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Illinois at Chicago

About this trial

The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (GVHD) prophylaxis will include Cyclophosphamide on Day +3 and +4, tacrolimus, and mycophenolate mofetil.

Eligibility criteria

Qualifiers

1. Age 18-65 years.

AML arising from MDS, a myeloproliferative disorder, or secondary AML

Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Poor-risk cytogenetics including 3q abnormalities, 7/7q minus or complex cytogenetics (>3 abnormalities).

Disqualifiers

1a. Left ventricular ejection fraction < 50%

2b. Creatinine clearance <30ml/min.

3c. Bilirubin > 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST > 5 x ULN.

4d. FEV1 and FVC < 50% of predicted or DLCO <50% of predicted once corrected for anemia.

Trial design

Treatments tested in this trial

Intensity modulated total marrow irradiation
Cyclophosphamide (CTX)
Fludarabine (Fludara)
Busulfan (conditioning for ALLO Transplant)

Treatment groups

38 Participants

are divided into 1 treatment group

Sponsors and collaborators

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov