Trials / Unknown

UnknownNCT01894477

Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

A Randomized Phase II Study of Treosulfan, Fludarabine and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)

Status: Unknown
Phase: Phase 2
Study type: Interventional
Enrollment: 102 (actual)

Sponsor: Fred Hutchinson Cancer Center · Academic / Other
Sex: All
Age: 70 Years
Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well treosulfan and fludarabine phosphate, with or without total body irradiation before donor stem cell transplant works in treating patients with myelodysplastic syndrome or acute myeloid leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus before and mycophenolate mofetil after the transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To determine the better of two treosulfan-based conditioning regimens in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), by comparing 6-month progression-free survival. SECONDARY OBJECTIVES: I. Determine the effects of two conditioning regimens on changes in gene expression profiles, and evaluate the association of gene expression profiles and disease relapse. II. Determine the incidence of progression-free survival at 1 year and 2 years after hematopoietic cell transplantation (HCT). III. Evaluate overall survival (OS) at 6 months, at 1 year and at 2 years after HCT. IV. Determine the incidence of grades II-IV acute graft-versus-host disease (GVHD). V. Determine the incidence of chronic GVHD. VI. Determine donor chimerism around days +28 and +84. CONDITIONING REGIMEN: Arm A: Patients receive treosulfan intravenously (IV) over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2. Arm B: Patients receive treosulfan and fludarabine phosphate as in Arm A and undergo low-dose total-body irradiation (TBI) on day 0. TRANSPLANT: Patients in both arms undergo allogeneic peripheral blood stem cell (PBSC) transplant or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients with a related donor receive tacrolimus orally (PO) every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, patients also receive mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, patients also receive mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96. NOTE: Patients with related donors eligible for FHCRC protocol 2545 may receive cyclosporine IV, instead of tacrolimus, beginning on day -3 to day 50 with a taper to day 180. After completion of study treatment, patients are followed up periodically.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Allogeneic Bone Marrow Transplantation	Undergo allogeneic bone marrow transplant
DRUG	Fludarabine Phosphate	Intravenously administered Fludarabine Phosphate
PROCEDURE	Peripheral Blood Stem Cell Transplantation	Undergo allogeneic PBSC transplant
RADIATION	Total-Body Irradiation	Undergo TBI
DRUG	Treosulfan	Intravenously administered Treosulfan
OTHER	Laboratory Biomarker Analysis	Correlative Studies

Timeline

Start date: 2013-11-01
Primary completion: 2017-01-09
Completion: 2022-06-01
First posted: 2013-07-10
Last updated: 2021-06-03
Results posted: 2018-05-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01894477. Inclusion in this directory is not an endorsement.