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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00860574
Other study ID # 2272.00
Secondary ID NCI-2010-00315P0
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2009

Study information

Verified date February 2021
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


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Study Design


Related Conditions & MeSH terms

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Intervention

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Locations

Country Name City State
United States University of Colorado Denver Colorado
United States Oregon Health and Science University Portland Oregon
United States Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse Incidence At 6 months
Primary Non Relapse Mortality (NRM) Incidence Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression. At 6 months
Secondary Non Relapse Mortality Incidence 1 year after HCT
Secondary Overall Survival (OS) at 2 years
Secondary Relapse-free Survival at 2 years
Secondary Incidence of Grades II-IV Acute GVHD at 6 months
Secondary Incidence of Chronic GVHD at 6 months
Secondary Median Donor CD3 + T Lymphocyte Chimerism in Peripheral Blood Donor chimerism was evaluated in peripheral blood T cells Day 28 after HCT
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