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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, AdultAcute Myeloid Leukemia RefractoryChronic Myeloid Leukemia - Accelerated PhaseMyelodysplastic 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Treatment RegimenExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

GVHD-Free Relapse-Free Survival after Stem Cell Transplant

The 1-year GVHD- free relapse-free survival after HSCT (hematopoietic stem cell transplantation) conditioned with a 9Gy TMI in combination with FluBu4 and PTCY in patients with acute myeloid leukemia (AML), chronic myeloid leukemia (CML), Myelodysplastic Syndrome (MDS) at high risk of relapse.

Time frame
1 Year Post-Stem Cell Transplant

Secondary outcomes

1

Overall Survival

The number of participants who have overall survival

Time frame
2 Years Post-Stem Cell Transplant
2

Time To Engraftment

Time frame
30 Days Post-Stem Cell Transplant
3

Adverse Events

The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0) and the Bearman scale.

Time frame
30 Days Post-Stem Cell Transplant
4

Adverse Events

The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0).

Time frame
60 Days Post-Stem Cell Transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov
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