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NCT03818334
Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies
Phase 2, PHASE3 trial testing Cyclophosphamide in Bone Marrow Transplant Complications in 50 participants. Currently enrolling.
1 November 2021
Quick facts
| Lead sponsor | Hospital Israelita Albert Einstein |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 50 |
| Start date | 6 November 2018 |
| Primary completion | 1 November 2021 |
| Estimated completion | 1 November 2026 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- ATG — full drug profile →
Conditions studied
- Bone Marrow Transplant Complications — all drugs for Bone Marrow Transplant Complications →
- Graft Versus Host Disease — all drugs for Graft Versus Host Disease →
- Infection Viral — all drugs for Infection Viral →
- Engraft Failure — all drugs for Engraft Failure →
Sponsor
Hospital Israelita Albert Einstein
Who can join
Adults 1 to 75, any sex, with Bone Marrow Transplant Complications or Graft Versus Host Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).
Publications & conference data
3 peer-reviewed publications 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 -
Post-transplantation Cyclophosphamide: From HLA-Haploidentical to Matched-Related and Matched-Unrelated Donor Blood and Marrow Transplantation.
Williams L, Cirrone F, Cole K, Abdul-Hay M, et al · · 2020 · cited 32× · PMID 32373119 · DOI 10.3389/fimmu.2020.00636 -
Current Preventions and Treatments of aGVHD: From Pharmacological Prophylaxis to Innovative Therapies.
Naserian S, Leclerc M, Shamdani S, Uzan G. · · 2020 · cited 16× · PMID 33391276 · DOI 10.3389/fimmu.2020.607030
Verify or expand the search:
- PubMed search for NCT03818334
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Bone Marrow Transplant Complications
Currently open trials in the same condition.
- NCT06590285 — Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation · NA · recruiting
- NCT06910969 — Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease · NA · recruiting
- NCT06541002 — A Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors · NA · recruiting
- NCT05709912 — Mobile CARE-App to Promote Coping for Caregivers of Patients Receiving Stem Cell Transplant · NA · active not recruiting
- NCT05629676 — Virtual Reality Intervention for Patients Undergoing BMT · NA · active not recruiting
Other Hospital Israelita Albert Einstein trials
Trials by the same sponsor.
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- NCT06726707 — COPPER: A Trial Evaluating Copper-based Products for Incontinence-associated Dermatitis · Phase 2, PHASE3 · withdrawn
- NCT07112846 — Prospective Clinical Registry for Evaluation of Exanthematous Infections and Coinfections · not yet 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 NCT03818334 (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 Hospital Israelita Albert Einstein
- Last refreshed: 1 February 2019
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/NCT03818334.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing