Phase 2
N=21
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
Aplastic Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00343785 ↗Enrolled (actual)
21
Serious AEs
23.8%
Results posted
Mar 2017
Primary outcome: Primary: Incidence of Chronic GVHD — 5 number participants with chronic GVHD
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cyclophosphamide (Drug); anti-thymocyte globulin (Biological); cyclosporine (Drug); allogeneic bone marrow transplantation (Procedure); methotrexate (Drug); DNA analysis (Genetic); flow cytometry (Other); polymorphism analysis (Genetic); laboratory biomarker analysis (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Chronic GVHD |
5 | — |
| SECONDARY Number of Days to Neutrophil Recovery to >500/uL |
26 | — |
| SECONDARY Overall Survival |
21 | — |
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) 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
Eligibility Criteria
Inclusion Criteria
- Any patient who has aplastic anemia with marrow failure involving 2 of the three following criteria: granulocytes 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
Data sourced from ClinicalTrials.gov (NCT00343785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.