Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies

Completed · Phase 2

Conditions studied: Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, Hematopoietic/Lymphoid Cancer, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Relapsing Chronic Myelogenous Leukemia

In brief

This phase II trial is studying the side effects and how well giving fludarabine phosphate, busulfan, anti-thymocyte globulin followed by donor peripheral blood stem cell transplant, tacrolimus, and methotrexate works in treating patients with myeloid malignancies. Giving chemotherapy, such as fludarabine phosphate and busulfan, before a donor 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. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving anti-thymocyte globulin before transplant and tacrolimus and methotrexate after transplant may stop this from happening.

Key facts

Study ID

NCT01056614

Run by

Fred Hutchinson Cancer Center

People needed

23

Starts

2004-09-01

Expected to finish

2016-04-01

Last updated by the study team

2016-05-06

Who can join

Age: any, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic myelogenous leukemia in chronic phase, accelerated phase and treated blast phase (CP2)
• Acute myeloid leukemia (AML) in remission or early relapse (< 10% marrow blasts)
• Myelodysplastic syndromes (MDS) ( all risk groups)
• Other myeloproliferative disorders
• DONOR: related or unrelated donors matched for human leukocyte antigen (HLA)-A, B, C, DRB1, and DQB1 defined by high resolution deoxyribonucleic acid (DNA) typing or mismatched for a single HLA-A, B, C, DRB1 or DQB1 allele
• DONOR: donor must consent to peripheral blood stem cell (PBSC) mobilization with granulocyte colony-stimulating factor (G-CSF) and leukapheresis; related donors will be collected at Fred Hutchinson Cancer Research Center (FHCRC), while unrelated donors will be collected through the National Marrow Donor Program (NMDP) or other donor centers
• DONOR: Age 12-75 yrs

You may not qualify if…

• Cardiac insufficiency requiring treatment or symptomatic coronary artery disease
• Hepatic disease, with aspartate aminotransferase (AST) > 2 times normal
• Severe hypoxemia, oxygen partial pressure (pO2) < 70 mm Hg, with decreased diffusion capacity of carbon monoxide (DLCO) < 70% of predicted; or mild hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted
• Impaired renal function (creatinine > 2 times normal or estimated creatinine clearance < 60 ml/min)
• MALE: ([140 -age in years] x ideal body weight [kg])/72 x serum creatinine (SCr) (mg/dL)
• FEMALE: .85 x ([140-age in years] x ideal body weight [kg])/72 x SCr (mg/dL)
• Human immunodeficiency virus (HIV)-positive patients due to risk of reactivation or acceleration of HIV replication
• Female patients who are pregnant or breast feeding
• Life expectancy severely limited by diseases other than malignancy
• DONOR: donors who for any reason are unable to tolerate the mobilization and leukapheresis procedure
• DONOR: donors who are HIV-positive, or hepatitis B or C antigen-positive
• DONOR: female donors who have a positive pregnancy test

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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