Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02224872

Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This research is being done to find out if bone marrow transplantation (BMT) followed by chemotherapy will help people with aplastic anemia who have failed other treatments.

You have a severe, life threatening disease (severe aplastic anemia) in your bone marrow. Your 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 yours but complications from Graft vs. Host disease (GVHD) and graft failure have limited the survival for those people.

A small study done at Johns Hopkins has shown that in subjects with other diseases (blood cancers) some immunosuppressive drugs given after the BMT have decreased how often subjects had complications of GVHD and engraftment failure.

People with aplastic anemia who have refractory disease (not responding to standard treatment) may join.

Status: 
Available
Study Date: 
Mon, 08/18/2014
Bone Marrow Disease(s): 
aplastic anemia
Intervention: 
Procedure: Bone marrow transplant Day 0 Drug: Thymoglobulin 0.5 mg/kg IV on Day -9 2 mg/kg IV on Days -8, -7 Drug: Fludarabine 30 mg/M2 IV on days -6 to -2 Drug: Cyclophosphamide 14.5 mg/kg IV on days -6, -5, 3, 4 Other Name: CTX Radiation: TBI 200 cGy on day -1 Drug: Mesna 40 mg/kg IV on days 3, 4 Drug: Tacrolimus Starting dose of 1 mg IV on day 5 for patients 18 years or older; may be increased or later changed to a PO BID schedule. Treatment to continue until Day 365 or longer if GVHD present Drug: Mycophenolic acid mofetil 15 mg/kg PO/IV TID beginning on day 5 through day 35 Other Name: MMF