Trials / Completed
CompletedNCT02833805
NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia
A Phase II Trial of Non-Myeloablative (NMA) Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Donor (MUD) Bone Marrow for Newly Diagnosed Patients With Severe Aplastic Anemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Our primary objective is to determine if it is feasible for previously untreated severe aplastic anemia (SAA) patients to be transplanted using non-myeloablative conditioning and post transplantation cyclophosphamide.
Detailed description
This is a clinical trial of upfront bone marrow transplantation for patients with SAA who do not have a fully human leukocyte antigen (HLA) matched donor. The trial uses a conditioning regimen which has been successful in the refractory and relapsed setting to maximize engraftment and post transplant therapy to minimize graft versus host disease (GVHD). This would be used here in patients who have not yet undergone immunosuppressive therapy for their SAA or are thought to be unlikely to respond to immunosuppressive therapy for SAA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Thymoglobulin | Day -9: 0.5 mg/kg Days -8 and -7: 2 mg/kg daily |
| DRUG | Fludarabine | Days -6 through -2: 30 mg/m\^2 IV daily |
| DRUG | Cyclophosphamide | Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily |
| RADIATION | Total body irradiation | Day -1: 200 centigray (cGy) in a single fraction |
| DRUG | Tacrolimus | Start on Day 5 through Day 365 |
| DRUG | Mycophenolate mofetil | Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day) |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2021-07-01
- Completion
- 2021-07-01
- First posted
- 2016-07-14
- Last updated
- 2022-07-12
- Results posted
- 2022-07-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02833805. Inclusion in this directory is not an endorsement.