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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2024
  • participants needed
    38
  • sponsor
    University of Illinois at Chicago
Updated on 24 February 2021
remission
fludarabine
tacrolimus
hla-a
myelodysplastic syndromes
busulfan
myeloproliferative disorder
methotrexate
antithymocyte globulin
cytopenia
refractory acute myeloid leukemia (aml)
secondary acute myeloid leukemia
flt3 internal tandem duplication
blast cells

Summary

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).

Description

Patients will receive the following conditioning regimen: fludarabine 40 mg/m2 IVBP daily for day -5 (5 days before stem cell infusion) through Day -2, IV busulfan targeting a 4800M/min/ day from day -5 through day -2, and ATG (Thymoglobulin) at 0.5 mg/kg IV on day -3, and 2 mg/kg on days -2 and day -1 (Only for recipients of stem cells from unrelated or mismatched donors). In addition to the above conditioning regimen all patients will receive TMI at a dose of 3Gy on days -3, -2 and -1. On day 0, the stem cell product will be infused according to BMT unit policy. Graft versus host disease (GVHD) prophylaxis will consist of administration of tacrolimus and methotrexate (see Section 8). Post-transplant evaluation will be done as per standard care with study data collected at day 30, 60, 90, 180, 365 and 2 years.

Details
Condition Bone marrow disorder, Preleukemia, Acute myeloid leukemia, MYELODYSPLASTIC SYNDROME, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), myelodysplastic syndromes, myelodysplastic syndrome (mds), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment methotrexate, busulfan, Fludarabine, Tacrolimus, Total Marrow Irradiation, ATG, Stem Cell Product Infusion
Clinical Study IdentifierNCT03121014
SponsorUniversity of Illinois at Chicago
Last Modified on24 February 2021

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