Recruiting
Phase 2

Total Marrow Irradiation

Sponsor:

University of Illinois at Chicago

Code:

NCT06802315

Conditions

Acute Myeloid Leukemia, Relapsed, Adult

Acute Myeloid Leukemia Refractory

Chronic Myeloid Leukemia - Accelerated Phase

Myelodysplastic Syndromes

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Intensity modulated total marrow irradiation

Cyclophosphamide (CTX)

Fludarabine (Fludara)

Busulfan (conditioning for ALLO Transplant)

Study Details

Brief summary:

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.

Conditions

Acute Myeloid Leukemia, Relapsed, Adult

Acute Myeloid Leukemia Refractory

Chronic Myeloid Leukemia - Accelerated Phase

Myelodysplastic Syndromes

Study ID

NCT06802315

Start date

Feb 4, 2025

Status verified date

Jun, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 1\. Age 18-65 years.
  • 2\. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in first remission, with remission defined as <5% bone marrow blasts morphologically:
  • 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: Monosomal karyotype, complex karyotype (> 3 abnormalities), inv (3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7. 2c. Primary refractory disease 2d. MDS with at least one of the following poor-risk features:
  • Poor-risk cytogenetics including 3q abnormalities, 7/7q minus or complex cytogenetics (>3 abnormalities).
  • Current or previous INT-2 or high IPSS score.
  • Treatment-related MDS.
  • MDS diagnosed before the age of 21 years.
  • Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy.
  • Life-threatening cytopenias, including those requiring regular PRBC or platelet transfusions. 2e. CML with a history of accelerated or blast phase.

Exclusion Criteria:

  • 1\. Presence of significant co-morbidity as shown by:
  • 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.
  • 5e. Karnofsky score <70
  • 6f. Active viral hepatitis or HIV infection.
  • 7g. Cirrhosis.
  • 2\. Pregnancy or breast feeding
  • 3\. Patients unable to sign informed consent.
  • 4\. Patients previously received radiation to >20% of bone marrow-containing areas.

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Regimen

Days -5 through -2: Fludarabine 40 mg/m2 IVPB daily and Busulfan targeting AUC 4800μM/min daily Day -3 through -1: Intensity modulated total marrow irradiation (9Gy fractionated) Day 0: Infuse peripheral blood mobilized stem cells Days +3 and +4: Cyclophosphamide 50 mg/kg/day Day 5: Mycophenolate mofetil and Tacrolimus (dose adjustment dependent on trough level) Day 30: Follow up Day 60: Follow up Day 90: Follow up Day 180: Follow up

1. year: Follow up
2. year: Follow up

Interventions

Intensity modulated total marrow irradiation

See "Treatment Regimen"

Cyclophosphamide (CTX)

This study will determine the safety of the combination of Total Marrow Irradiation (TMI) and Post-Transplant Cyclophosphamide using a myeloablative fludarabine and iv targeted busulfan (Flu/Bu4) conditioning regimen.

Fludarabine (Fludara)

chemotherapy conditioning

Busulfan (conditioning for ALLO Transplant)

chemotherapy conditioning

Primary outcome measure

  • GVHD-Free Relapse-Free Survival after Stem Cell Transplant [ Time Frame: 1 Year Post-Stem Cell Transplant ]

Central Contacts and Locations

Central contacts

Matias Sanchez, MD

(312) 413-4260matiass@uic.edu

Marisol Vega, MPH

(312) 413-5035vegam35@uic.edu

Locations

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Matias Sanchez, MD

(312) 413-4260matiass@uic.edu

Marisol Vega, MPH

(312) 413-5035vegam35@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Total Marrow Irradiation
  • Stem Cell Transplant
  • Allogenic Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-06-26.