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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborators: National Cancer Institute (NCI); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Antilymphocyte Serum; Busulfan; Fludarabine; Fludarabine phosphate; Immunoglobulins; Methotrexate; Tacrolimus; Thymoglobulin; Vidarabine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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