Trials / Completed

CompletedNCT00860574

Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia

A Multi-Center Study of Conditioning With Treosulfan, Fludarabine and Escalating Doses of TBI for Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS), and Acute Lymphoblastic Leukemia (ALL)

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 96 (actual)

Sponsor: Fred Hutchinson Cancer Center · Academic / Other
Sex: All
Age: 60 Years
Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving treosulfan together with fludarabine phosphate and total-body irradiation followed by donor stem cell transplant works in treating patients with high-risk acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor bone marrow or peripheral blood 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 and methotrexate before and after transplant may stop this from happening

Detailed description

PRIMARY OBJECTIVES: I. Decrease the incidence of relapse to \< 15% at 6 month post transplant in patients with high risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) transplanted from related or unrelated donors, without unacceptably increasing toxicity (10% non-relapse mortality \[NRM\] at 6 months). SECONDARY OBJECTIVES: I. Evaluate the incidence of NRM at 180 days and 1 year after hematopoietic cell transplantation (HCT). II. Evaluate overall survival (OS) and relapse-free survival (RFS). III. Incidence of grades II-IV acute graft-versus-host disease (GVHD). IV. Incidence of chronic GVHD. V. Donor chimerism on days +28 and +100. OUTLINE: CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally (PO) twice daily (BID) on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. After completion of study treatment, patients are followed up periodically.

Conditions

Interventions

Type	Name	Description
DRUG	treosulfan	Given IV
DRUG	fludarabine phosphate	Given IV
RADIATION	total-body irradiation	Low dose starting at 2Gy
PROCEDURE	peripheral blood stem cell transplantation	Given IV per institutional standard practice
DRUG	tacrolimus	Given IV or PO
PROCEDURE	allogeneic bone marrow transplantation	Given IV per institutional standard practice
PROCEDURE	allogeneic hematopoietic stem cell transplantation	Given IV per institutional standard practice
DRUG	methotrexate	Given IV

Timeline

Start date: 2009-02-01
Primary completion: 2013-02-01
First posted: 2009-03-12
Last updated: 2021-06-22
Results posted: 2021-02-26

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00860574. Inclusion in this directory is not an endorsement.