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Efficacy and safety of ruxolitinib in preventing aGVHD after haplotype bone marrow transplantation in severe aplastic anemia

Efficacy and safety of ruxolitinib in preventing aGVHD after haplotype bone marrow transplantation in severe aplastic anemia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051874
Enrollment
Unknown
Registered
2021-10-08
Start date
2021-10-01
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Severe aplastic anemia

Interventions

Sponsors

The Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Must be able to understand the trial protocol, follow the doctor's instructions and sign the informed consent; 2. Aged = 3 months; 6. No serious comorbidities, AST, ALT, bilirubin within 2 weeks before enrollment is less than 2.5 times the upper limit of normal, serum creatinine is less than 2 times the upper limit of normal, myocardial enzyme is less than 2 times the upper limit of normal; 7. The viral hepatitis virus DNA copy number does not exceed 5x10^2 copy number; 8. Haplotype donors with HLA high-resolution matching (A, B, C, DR, DQ) haploidentical (>=5/10), the donor age is 8-65 years old, and there is no contraindication for donating stem cells (Excluding hematological diseases, malignant tumors, infectious diseases, severe organ insufficiency, mental diseases, etc.); 9. No active infection; 10. Females of reproductive age must have a negative pregnancy test and agree to use effective contraception during treatment and for the following year.

Exclusion criteria

Exclusion criteria: 1. Diagnose paroxysmal nocturnal hemoglobinuria, myelodysplastic syndrome, congenital genetic diseases and other diseases; 2. Specific allergic constitution, allergic to ruxolitinib; 3. HBV active viral hepatitis, HCV antibody positive, HIV positive; 4. Serious disease that may limit patient participation in this trial (eg, advanced infection: deep fungal infection and/or active infection, drug-resistant bacterial infection, sepsis, uncontrolled diabetes, severe cardiac insufficiency or angina pectoris, liver and kidney insufficiency, severe respiratory disease); 5. Those who are participating in other clinical trials or have participated in other drug clinical trials within 3 months; 6. Breastfeeding patients; 7. Mental state is unstable; 8. Patients who are deemed unsuitable for treatment by this regimen according to the investigator.

Design outcomes

Primary

MeasureTime frame
Incidence of acute graft-versus-host disease;

Countries

China

Contacts

Public ContactYan Jinsong

The Second Affiliated Hospital of Dalian Medical University

yanjsdmu@126.com+86 17709871028

Outcome results

None listed

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