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NCT04859946
Itacitinib for the Prevention of Graft Versus Host Disease
Phase 2 trial testing Allogeneic Hematopoietic Stem Cell Transplantation in Hematologic and Lymphocytic Disorder in 31 participants. Participants enrolled and being followed up; not accepting new ones.
1 April 2027
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 31 |
| Start date | 11 January 2022 |
| Primary completion | 1 April 2027 |
| Estimated completion | 1 April 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Allogeneic Hematopoietic Stem Cell Transplantation
- Busulfan — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Itacitinib
- Tacrolimus
- Thiotepa — full drug profile →
Conditions studied
- Hematologic and Lymphocytic Disorder — all drugs for Hematologic and Lymphocytic Disorder →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
Adults 18 to 70, any sex, with Hematologic and Lymphocytic Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. An allogeneic transplant uses blood-making cells from a family member or unrelated donor to remove and replace a patient's abnormal blood cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Giving itacitinib with standard of care treatment after the transplant may stop this from happening.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Controversies and expectations for the prevention of GVHD: A biological and clinical perspective.
Watkins B, Williams KM. · · 2022 · cited 20× · PMID 36505500 · DOI 10.3389/fimmu.2022.1057694 -
Translational Clinical Strategies for the Prevention of Gastrointestinal Tract Graft <i>Versus</i> Host Disease.
Rayasam A, Drobyski WR. · · 2021 · cited 5× · PMID 34899738 · DOI 10.3389/fimmu.2021.779076 -
How to improve the outcomes of elderly acute myeloid leukemia patients through allogeneic hematopoietic stem cell transplantation.
Jiang S, Yan H, Lu X, Wei R, et al · · 2023 · cited 1× · PMID 37207218 · DOI 10.3389/fimmu.2023.1102966
Verify or expand the search:
- PubMed search for NCT04859946
- 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.
- NCT06954987 — Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell · Phase 2 · not yet recruiting
- 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 recruiting trials for Hematologic and Lymphocytic Disorder
Currently open trials in the same condition.
- NCT04572815 — Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant · Phase 2 · active not recruiting
- NCT04062266 — AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission · Phase 2 · active not recruiting
- NCT03207854 — Collection of Immunology Specimens From Patients With Cancer or Blood Disorders, and Healthy Volunteers · recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
- NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
- NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · 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 NCT04859946 (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: 16 April 2026
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/NCT04859946.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing