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NCT06128070
Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
Phase 2 trial testing Biospecimen Collection in Acute Lymphoblastic Leukemia in 40 participants. Currently enrolling.
22 November 2030
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 16 July 2024 |
| Primary completion | 22 November 2030 |
| Estimated completion | 22 November 2030 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Biospecimen Collection — full drug profile →
- Chest Computed Tomography
- Echocardiography
- Hematopoietic Cell Transplantation — full drug profile →
- Methotrexate — full drug profile →
- Multigated Acquisition Scan
- Ruxolitinib Phosphate
- Tacrolimus (TACROLIMUS) — full drug profile →
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
Sponsor
City of Hope Medical Center
Who can join
Adults 2 to 22, any sex, with Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial tests how well ruxolitinib with tacrolimus and methotrexate work to prevent the development of graft versus host disease in pediatric and young adult patients undergoing allogeneic hematopoietic cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Ruxolitinib is a type of medication called a kinase inhibitor. It works by blocking the signals of cells that cause inflammation and cell proliferation, which may help prevent graft versus host disease (GVHD). Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants by suppressing the immune system. Methotrexate stops cells from making DNA, may kill cancer cells, and also suppress the immune system, which may reduce the risk of GVHD. Giving ruxolitinib with tacrolimus and methotrexate may prevent GVHD in pediatric and young adults undergoing allogeneic hematopoietic cell transplants.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Novel Therapeutic Approaches in Pediatric Acute Lymphoblastic Leukemia.
Marrapodi MM, Di Paola A, Di Feo G, Di Domenico O, et al · · 2025 · PMID 41373522 · DOI 10.3390/ijms262311362
Verify or expand the search:
- PubMed search for NCT06128070
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other City of Hope Medical Center trials
Trials by the same sponsor.
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- NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
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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 NCT06128070 (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 City of Hope Medical Center
- Last refreshed: 31 October 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/NCT06128070.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing