drugset / Trial / NCT02838992
ATG Combined With Cyclophosphamide And Cord Blood Transfusion in Treating Patients With Severe Aplastic Anemia
Phase 4
Unknown
130 enrolled
Jinan Military General Hospital
Guangzhou First People's Hospital · collabHarbin Hematology and Oncology Institute · collabInstitute of Hematology & Blood Diseases Hospital, China · collabJiangxi Provincial People's Hopital · collabJinhua Central Hospital · collabJining First People's Hospital · collabJining Medical University · collabLinyi People's Hospital · collabQingdao Hiser Medical Group · collabQingdao University · collabShandong Cord Blood Bank · collabShandong University of Traditional Chinese Medicine · collabShengjing Hospital · collabTaian City Central Hospital · collabWeifang Medical University · collabYantai Yuhuangding Hospital · collabYishui Central Hospital of LINYI · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To assess whether ATG Combined With Cyclophosphamide and cord blood infusion can accelerate hematopoietic reconstruction in severe aplastic anemia patients and improve clinical curative effect and safety
Timeline
- Start
- 2017-02
- Primary completion
- 2018-12
- Completion
- 2019-07
Publications
- Background Killick SB, Bown N, Cavenagh J, Dokal I, Foukaneli T, Hill A, Hillmen P, Ireland R, Kulasekararaj A, Mufti G, Snowden JA, Samarasinghe S, Wood A, Marsh JC; British Society for Standards in Haematology. Guidelines for the diagnosis and management of adult aplastic anaemia. Br J Haematol. 2016 Jan;172(2):187-207. doi: 10.1111/bjh.13853. Epub 2015 Nov 16. No abstract available.
- Results Zhou F, Ge L, Yu Z, Fang Y, Kong F. Clinical observations on intensive immunosuppressive therapy combined with umbilical cord blood support for the treatment of severe aplastic anemia. J Hematol Oncol. 2011 Jun 10;4:27. doi: 10.1186/1756-8722-4-27.
- Results Xie LN, Fang Y, Yu Z, Song NX, Kong FS, Liu XM, Zhou F. Increased immunosuppressive treatment combined with unrelated umbilical cord blood infusion in children with severe aplastic anemia. Cell Immunol. 2014 May-Jun;289(1-2):150-4. doi: 10.1016/j.cellimm.2014.03.014. Epub 2014 Apr 3.
- Results Yu Z, Zhou F, Ge LF, Liu XM, Fang Y, Xie LN, Kong FS, Song NX, Yu QQ. Mechanism of immunosuppressants combined with cord blood for severe aplastic anemia. Int J Clin Exp Med. 2015 Feb 15;8(2):2484-94. eCollection 2015.
- Results Xie LN, Zhou F. Unexpected unrelated umbilical cord blood stem cell engraft in two patients with severe aplastic anemia that received immunosuppressive treatment: A case report and literature review. Exp Ther Med. 2015 Oct;10(4):1563-1565. doi: 10.3892/etm.2015.2698. Epub 2015 Aug 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | — |
| Subject | Influenza Virus Vaccine | Vaccine | — | Other |
| Background | Cyclosporine | Peptide | 5 mg/kg | — |
| Background | Thymoglobulin | Protein / enzyme biologic | 3 mg/kg | Other |