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NCT04127721
Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation
Phase 2 trial testing Allogeneic Hematopoietic Stem Cell Transplantation in Allogeneic Stem Cell Transplant Recipient. Withdrawn.
22 September 2020
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Start date | 22 September 2020 |
| Primary completion | 22 September 2020 |
| Estimated completion | 22 September 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Allogeneic Hematopoietic Stem Cell Transplantation — full drug profile →
- Busulfan — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Itacitinib
- Methotrexate
- Tacrolimus (TACROLIMUS) — full drug profile →
Conditions studied
- Allogeneic Stem Cell Transplant Recipient — all drugs for Allogeneic Stem Cell Transplant Recipient →
- Hematologic and Lymphocytic Disorder — all drugs for Hematologic and Lymphocytic Disorder →
- Hematopoietic and Lymphoid Cell Neoplasm — all drugs for Hematopoietic and Lymphoid Cell Neoplasm →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
Adults 18 to 75, any sex, with Allogeneic Stem Cell Transplant Recipient or Hematologic and Lymphocytic Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies how well itacitinib works in preventing graft versus host disease in patients with blood disorders undergoing donor stem cell transplantation. A donor transplantation uses blood-making cells from a family member or unrelated donor to remove and replace abnormal blood cells. Graft versus host disease is a reaction of the donor's immune cells against the patient's body. Itacitinib plus standard treatment may help prevent graft versus host disease in patients who have received a donor stem cell transplantation.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Insights into the role of the JAK/STAT signaling pathway in graft-<i>versus</i>-host disease.
Abboud R, Choi J, Ruminski P, Schroeder MA, et al · · 2020 · cited 33× · PMID 32537114 · DOI 10.1177/2040620720914489 -
Janus kinase inhibition in the treatment and prevention of graft-versus-host disease.
De Togni E, Cole O, Abboud R. · · 2024 · cited 7× · PMID 38380328 · DOI 10.3389/fimmu.2024.1304065 -
How to Make an Immune System and a Foreign Host Quickly Cohabit in Peace? The Challenge of Acute Graft-<i>Versus</i>-Host Disease Prevention After Allogeneic Hematopoietic Cell Transplantation.
Vandenhove B, Canti L, Schoemans H, Beguin Y, et al · · 2020 · cited 7× · PMID 33193397 · DOI 10.3389/fimmu.2020.583564
Verify or expand the search:
- PubMed search for NCT04127721
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Allogeneic Hematopoietic Stem Cell Transplantation
Trials testing the same drug.
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- NCT04579523 — ²¹¹At-OKT10-B10 and Fludarabine Alone or in Combination With Cyclophosphamide and Low-Dose TBI Before Donor Stem Cell Tr · Phase 1 · not yet recruiting
- NCT07349771 — Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoie · Phase 2 · not yet recruiting
- NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients · NA · recruiting
- NCT07228624 — Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplas · Phase 2 · recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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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 NCT04127721 (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 M.D. Anderson Cancer Center
- Last refreshed: 29 October 2020
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/NCT04127721.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing