Who is sponsoring NCT03121014?

NCT03121014 is sponsored by University of Illinois at Chicago.

What condition does NCT03121014 study?

NCT03121014 studies Acute Myeloid Leukemia, Myelodysplastic Syndromes.

What drugs are being tested in NCT03121014?

Interventions: Fludarabine, Busulfan, ATG, Total Marrow Irradiation, Stem Cell Product Infusion, Tacrolimus, Methotrexate.

What is the status of NCT03121014?

NCT03121014 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2026-01-12 · How we verify

A Phase II 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

NCT03121014 Phase 2 ACTIVE_NOT_RECRUITING

The study is a Phase II clinical trial. Patients will receive intensity modulated total marrow irradiation (TMI) at a dose of 9 Gy with standard myeloablative fludarabine/ i.v. targeted busulfan (FluBu) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT).

Details

Lead sponsor	University of Illinois at Chicago
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	38
Start date	2017-04-24
Completion	2026-04

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndromes

Interventions

Fludarabine
Busulfan
ATG
Total Marrow Irradiation
Stem Cell Product Infusion
Tacrolimus
Methotrexate

Primary outcomes

Relapse free survival of approximately 30% in high-risk patients conditioned with the Fludarabine/ Busulfan regimen — Up to 1 year
Using a Simon 2 stage optimal design with α of 0.05 and power of 0.8, 15 patients will be enrolled in the first stage. If greater than 5 patients survive to 1 year without relapse the study will continue into stage 2. Recruitment will then continue to a total of 46 patients. In this expanded cohort, if a total of 18 or more patients survive to 1 year without relapse, the treatment will be judged efficacious and worthy of further study.

Countries

United States