Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant

Completed · Phase 2

Conditions studied: Aplastic Anemia

In brief

This clinical trial is studying how well giving cyclophosphamide together with anti-thymocyte globulin followed by methotrexate and cyclosporine works in preventing chronic graft-vs-host disease (GVHD) in patients with severe aplastic anemia undergoing donor bone marrow transplant. Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving anti-thymocyte globulin before and methotrexate and cyclosporine after transplant may stop this from happening

Key facts

Study ID

NCT00343785

Run by

Fred Hutchinson Cancer Center

People needed

21

Starts

2006-02-01

Expected to finish

2012-08-01

Last updated by the study team

2017-04-13

Who can join

Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient who has aplastic anemia with marrow failure involving 2 of the three following criteria: granulocytes < 500/uL; a corrected reticulocyte count of < 1%; platelet count of < 20,000/uL
• Availability of an human leukocyte antigen (HLA)-matched family member
• DONOR: Family member who is HLA-matched
• DONOR: If more than one HLA-matched family member is available, priority will be given to a donor who is genotypically HLA-identical, of appropriate cytomegalovirus (CMV) serology, ABO compatible, and, in case of a female donor, non-parous

You may not qualify if…

• Severe disease other than aplastic anemia that would severely limit the probability of survival during the graft procedure:
• Patients who have developed clonal cytogenetic abnormalities or myelodysplastic syndrome (preleukemia)
• Patients with Fanconi's anemia
• Aplasia secondary to radiation or cytotoxic chemotherapy
• Patients with paroxysmal nocturnal hemoglobinuria who have not developed aplastic anemia
• Severe organ toxicities:
• Cardiac insufficiency requiring treatment or symptomatic coronary artery disease;
• Severe hypoxemia , partial pressure of oxygen (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 upper limit of normal or estimated creatinine clearance < 60 ml/min)
• Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
• Human immunodeficiency virus (HIV)-positive patients
• Females who are pregnant or breast-feeding
• DONOR: Donors who have increase anesthetic risk and are not able psychologically and medically to tolerate the procedure
• DONOR: HIV-positive donors

Where it is running

• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
• Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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