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)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT06802315
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Intensity modulated total marrow irradiation — RADIATION
    See "Treatment Regimen"
  • Cyclophosphamide (CTX) — DRUG
    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) — DRUG
    chemotherapy conditioning
  • Busulfan (conditioning for ALLO Transplant) — DRUG
    chemotherapy conditioning

Study Details

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.

Key Dates

Start date
Feb 4, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2030
Completion
Mar 31, 2032

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612
Matias Sanchez, MD
[email protected]
312-413-4260
Marisol Vega, MPH
[email protected]
(312) 413-5035

Find similar trials in Chicago, IL

By research site
University of Illinois Cancer Center· Chicago, IL

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