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NCT02845596
Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic Anemia
NA trial testing cyclosporine in Severe Aplastic Anemia in 40 participants. Completed in 19 July 2023.
3 November 2020
Quick facts
| Lead sponsor | Michael Pulsipher |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 1 August 2016 |
| Primary completion | 3 November 2020 |
| Estimated completion | 19 July 2023 |
| Sites | 13 locations across United States |
Drugs / interventions tested
- cyclosporine (cyclosporine) — full drug profile →
- Matched Unrelated Donor Hematopoietic Stem Cell Transplant
- horse anti-thymocyte globulin (ATG)
- rabbit anti-thymocyte globulin (ATG) — full drug profile →
- methotrexate
- fludarabine (FLUDARABINE) — full drug profile →
- cyclophosphamide (cyclophosphamide) — full drug profile →
- low-dose total body irradiation (TBI)
- Immunosuppressive Therapy (IST) — full drug profile →
Conditions studied
- Severe Aplastic Anemia — all drugs for Severe Aplastic Anemia →
Sponsor
Michael Pulsipher — full company profile →
Who can join
Under 25, any sex, with Severe Aplastic Anemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of patients randomized to HSCT that actually complete HSCT
Time frame: 4 years
Feasibility of comparing outcomes of patients treated de novo with IST versus matched unrelated donor HSCT for pediatric acquired severe aplastic anemia as defined by percentage of patients randomized to HSCT that actually complete HSCT.
Sponsor's own description
The purpose of this study is to determine the feasibility of comparing outcomes of patients treated de novo with immunosuppressive therapy (IST) versus matched unrelated donor (MUD) hematopoietic stem cell transplant (HSCT) for pediatric acquired severe aplastic anemia.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Severe aplastic anemia: allogeneic bone marrow transplantation as first-line treatment.
Georges GE, Doney K, Storb R. · · 2018 · cited 91× · PMID 30108110 · DOI 10.1182/bloodadvances.2018021162 -
Future directions in transplantation for aplastic anemia.
Sharma A. · · 2025 · PMID 41348014 · DOI 10.1182/hematology.2025000767
Verify or expand the search:
- PubMed search for NCT02845596
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of cyclosporine
Trials testing the same drug.
- NCT06837259 — A Study to Learn if Study Medicines Called Cyclosporine and Clarithromycin Affect How the Body Processes the Other Study · Phase 1 · completed
- NCT06642909 — A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy · Phase 2 · active not recruiting
- NCT06509243 — Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis · NA · completed
- NCT04979884 — Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria University Hospital · Phase 3 · completed
- NCT04743739 — Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN · Phase 3 · terminated
Other recruiting trials for Severe Aplastic Anemia
Currently open trials in the same condition.
- NCT06622694 — CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic Anemia · Phase 1 · recruiting
- NCT06517641 — Clinical Trial of Upfront Haploidentical or Unrelated Donor BMT to Restore Normal Hematopoiesis in Aplastic Anemia · Phase 2 · recruiting
- NCT06695741 — Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia · Phase 2 · recruiting
- NCT06412497 — MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Se · Phase 2 · recruiting
- NCT06378060 — Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02845596 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Michael Pulsipher
- Last refreshed: 6 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02845596.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing