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NCT03088709
Haploidentical Stem Cell Transplantation Using Post-Transplant Cyclophosphamide
Phase 2 trial testing Cyclophosphamide in Acute Myeloid Leukemia in 5 participants. Terminated before completion.
31 January 2022
Quick facts
| Lead sponsor | Loyola University |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 5 |
| Start date | 18 January 2017 |
| Primary completion | 31 January 2022 |
| Estimated completion | 31 January 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Tacrolimus (TACROLIMUS) — full drug profile →
- Mycophenolate mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
- Haploidentical Stem Cell Transplantation — full drug profile →
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- Acute Lymphocytic Leukemia — all drugs for Acute Lymphocytic Leukemia →
- Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
- Non-hodgkin Lymphoma — all drugs for Non-hodgkin Lymphoma →
Sponsor
Loyola University
Who can join
Adults 16 to 90, any sex, with Acute Myeloid Leukemia or Acute Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Historically, the best results of allogeneic SCT have been obtained when the stem cell donor is a human leukocyte antigen (HLA)-matched sibling, however, this is only available for approximately 30 percent of patients in need for SCT. Alternative donor sources include matched unrelated donor utilizing the donor registry, cord blood transplant and mismatched donor transplant. A human leukocyte antigen (HLA)-haploidentical donor is one who shares, by common inheritance, exactly one HLA haplotype with the recipient, and includes the biologic parents, biologic children and full or half siblings. There is strong body of evidence supporting the use of haplo-SCT in patient who lack a matched sibling or unrelated donor with high rates of successful engraftment, effective Graft Versus Host Disease (GVHD) control and favorable outcomes comparative to those seen using other allograft sources, including HLA-matched sibling SCT. Furthermore, it provides a cost-efficient donor option in a timely manner especially for patients who need to proceed quickly to transplant due to concern of disease relapse/progression.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prevention and Treatment of Acute Graft-versus-Host Disease in Children, Adolescents, and Young Adults.
Gatza E, Reddy P, Choi SW. · · 2020 · cited 41× · PMID 31931115 · DOI 10.1016/j.bbmt.2020.01.004
Verify or expand the search:
- PubMed search for NCT03088709
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03088709 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Loyola University
- Last refreshed: 10 July 2024
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/NCT03088709.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing