Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies | Aplastic Anemia & MDS International Foundation
Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Clinical Trial: NCT04195633

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM A (HIGH DOSE TREOSULFAN): Patients receive high dose treosulfan intravenously (IV) over 120 minutes on days -6 to -4 and fludarabine IV over 60 minutes on days -6 to -2. Patients then undergo total-body irradiation on day -1 and allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive cyclophosphamide IV over 1-2 hours on days 3-4. Beginning on day 5, patients receive cyclosporine IV twice daily (BID) over 1-2 hours or orally (PO) (after 3 months, in the absence of GVHD, cyclosporine tapering will start by 5-10% per week, until drug withdrawal at 6 months post-transplant). Beginning on day 5, patients also receive mycophenolate sodium PO three times daily (TID) or mycophenolate mofetil IV or PO TID until day 35 (may be continued if active GVHD is present). Beginning on day 5, patients also receive filgrastim until the absolute neutrophil count is > 1,000/uL for 3 consecutive days.

ARM B (LOW DOSE TREOSULFAN): Patients receive low dose treosulfan IV over 120 minutes on days -6 to -4 and fludarabine IV over 60 minutes on days -6 to -2. Patients then undergo total-body irradiation and allogeneic hematopoietic stem cell transplantation, and receive cyclophosphamide, cyclosporine, mycophenolate sodium or mycophenolate mofetil, and filgrastim as in Arm A.

After completion of transplant, patients are followed up at 28, 56, 84, 365, and 730 days.

Status: 
Not yet recruiting
Study Date: 
Wed, 07/01/2020 to Tue, 12/27/2022
Bone Marrow Disease(s): 
  • acute myeloid leukemia (AML)
  • chronic myelomonocytic leukaemia (CMML)
  • myelodysplastic syndromes (MDS)
Intervention: 
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Undergo allogeneic hematopoietic stem cell transplantation Other Names: Allogeneic Hematopoietic Cell Transplantation Allogeneic Stem Cell Transplantation HSC HSCT Stem Cell Transplantation, Allogeneic Drug: Cyclophosphamide Given IV Other Names: (-)-Cyclophosphamide 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate Carloxan Ciclofosfamida Ciclofosfamide Cicloxal Clafen Claphene CP monohydrate CTX CYCLO-cell Cycloblastin Cycloblastine Cyclophospham Cyclophosphamid monohydrate Cyclophosphamide Monohydrate Cyclophosphamidum Cyclophosphan Cyclophosphane Cyclophosphanum Cyclostin Cyclostine Cytophosphan Cytophosphane Cytoxan Fosfaseron Genoxal Genuxal Ledoxina Mitoxan Neosar Revimmune Syklofosfamid WR- 138719 Drug: Cyclosporine Given IV or PO Other Names: 27-400 Ciclosporin CsA Cyclosporin Cyclosporin A Cyclosporine Modified Gengraf Neoral OL 27-400 Sandimmune SangCya Biological: Filgrastim Given IV Other Names: G-CSF Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor rG-CSF Tevagrastim Drug: Fludarabine Given IV Other Name: Fluradosa Drug: Mycophenolate Mofetil Given IV or PO Other Names: Cellcept MMF Drug: Mycophenolate Sodium Given PO Other Names: ERL 080 ERL 080A Socium Mycophenolate Radiation: Total-Body Irradiation Undergo total-body irradiation Other Names: TBI Total Body Irradiation Whole Body Irradiation Whole-Body Irradiation Drug: Treosulfan Given IV Other Names: 1,2,3, 4-Butanetetrol, 1,4-dimethanesulfonate, [R-(R*,S*)]- Dihydroxybusulfan Ovastat Treosulphan Tresulfon