Bone Marrow Transplant Trial for Patients With Refractory Severe Aplastic Anemia
Stopped early · Phase 2
Conditions studied: Severe Aplastic Anemia
In brief
Patients with severe, refractory aplastic anemia have a severe, life threatening disease in their bone marrow. Refractory disease means that disease has come back or not responded after receiving one or more immunosuppressive treatments. High dose chemotherapy followed by bone marrow transplantation (BMT) has been used to treat blood diseases like aplastic anemia but complications from Graft vs Host disease (GVHD) and graft failure have limited the survival for those patients. Another study done here at Johns Hopkins has shown that in patients with other diseases (blood cancers) some immunosuppressive drugs given after the BMT has decreased how often patients had complications of GVHD and engraftment failure. This research is being done to find if this approach will help patients with aplastic anemia who have failed other treatments will have better outcomes.
Key facts
- Study ID
- NCT01383434
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 4
- Starts
- 2011-06-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2016-10-13
Who can join
Age: 1 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients who have refractory or relapsed SAA following treatment with one or more immunosuppressive regimens.
- Age 6 months - 70 years
- Patients must meet medical criteria for myeloablative BMT
- Patients or their parents/guardians and donors must be able to sign consent forms.
- Patients must be geographically accessible and willing to participate in all stages of treatment.
You may not qualify if…
- Poor cardiac function: left ventricular ejection fraction <45% as determined by MUGA or ECHO.
- Poor pulmonary function: FEV1 and FVC <50% predicted.
- Poor renal function
- Positive leukocytotoxic crossmatch
- Women of childbearing potential who currently are pregnant (Β-HCG+) or who are not practicing adequate contraception
- Uncontrolled viral, bacterial, or fungal infections
Where it is running
- The Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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