Status:
COMPLETED
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
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Aplastic Anemia
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: I. Minimize the incidence of chronic GVHD by restricting the transplanted marrow dose to 2.0-2.5 x 10\^8 nucleated cells/kg. SECONDARY OBJECTIVES: I. Engraftment and overall sur...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00343785
Start Date
February 1 2006
End Date
August 1 2012
Last Update
April 13 2017
Active Locations (3)
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1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
2
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
3
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226