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The efficacy and safety of ruxolitinib in allogeneic hematopoietic stem cell transplantation for GVHD prophylaxis in siblings aged =40 years: a multicenter, open, randomized, controlled clinical trial

The efficacy and safety of ruxolitinib in allogeneic hematopoietic stem cell transplantation for GVHD prophylaxis in siblings aged =40 years: a multicenter, open, randomized, controlled clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072481
Enrollment
Unknown
Registered
2023-06-14
Start date
2022-11-17
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic setm cell transplantation

Interventions

Treatment group:PT/CY+ CSA/FK506+RUX
Control group:ATG+CSA/FK506+MMF+MTX

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: ) Age: 40-65 years old; 2) Gender: both male and female; 3) Patients with hematologic malignancies (including acute leukemia-CR1, CR2, chronic myeloid leukemia-CP, and AP) in the standard risk group and myelodysplastic syndromes -RA,RARS,RCMD,RAEB-1, RAEB-2); 4) HLA-identical sibling allogeneic hematopoietic stem cell transplantation; 5) In general condition, ECOG score =1 6) Normal cardiac function: ejection fraction =50%; 7) Normal liver and renal function: blood bilirubin =35µmol/L, AST/ALT below 2 times the upper limit of normal value, blood muscle anhydride <= 130 mol/L; 8) Subjects sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe infection was not controlled before transplantation; (2) severe allergy to ruxolitinib (anaphylactic shock or laryngeal edema); (3) Unrelated allogeneic hematopoietic stem cell transplantation, haploid transplantation and reduced pretreatment dose transplantation; (4) Patients with cardiac dysfunction (ejection fraction 130umol/L); (6) Liver dysfunction (total bilirubin >34umol/L,ALT, AST> 2 times the upper limit of normal); (7) Previous hematopoietic stem cell transplantation history; (8) Other circumstances that do not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
acute graft-versus-host disease;

Secondary

MeasureTime frame
Incidence of infection;chornic graft-versus-host disease;non-relapse mortality;Overall survival;Disease-free survival;

Countries

China

Contacts

Public Contactzhoujian

Henan cancer hospital

zhoujiandoctor@163.com+86 136 2382 2347

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026