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Clinical study for ruxolitinib in the prevention of acute graft-versus-host disease

A multicenter, randomized controlled clinical trial for the prevention of acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (HSCT) with ruxolitinib

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027971
Enrollment
Unknown
Registered
2019-12-07
Start date
2019-12-04
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

Malignant hematopathy

Interventions

Experimental group:Ruxolitinib+CSA+MTX+MMF
Control group:CSA+MTX+MMF

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with acute leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, chronic myeloid leukemia and lymphoma diagnosed according to the WHO classification criteria for hematopoietic and lymphoid tissue tumors in 2017; patients with aplastic anemia diagnosed according to the Chinese Expert Consensus on Diagnosis and Treatment of Aplastic Anemia (2017 edition) Patients with obstructive anemia. The indications for transplantation refer to the consensus of Chinese experts on allogeneic hematopoietic stem cell transplantation for the treatment of hematological diseases (2014 edition); 2. recipients of allogeneic hematopoietic stem cell transplantation (including HLA-compatible or incomplete-compatible allogeneic stem cell transplantation and unrelated donor transplantation); 3. male or female aged 15-65 years; 4. ECOG score 0-2; 5. Informed consent must be signed before the start of the research procedure. Informed consent should be signed by the patient himself or his immediate relatives aged 18 years or over. Informed consent should be signed by legal guardians for adolescents under 18 years of age.

Exclusion criteria

Exclusion criteria: 1. received hematopoietic stem cell transplantation within the past 1 year; 2. Patients who had developed GVHD before enrollment 3. uncontrolled active infections, including significant bacterial, fungal, viral or parasitic infections requiring treatment; 4. evidence of active viral infection (confirmed by peripheral blood viral load measurement), including CMV, EBV, HBV or HCV, HIV; 5. evidence of active TB; 6. severe respiratory diseases; 7. mental disorders can not meet the requirements of research, treatment and monitoring; 8. pregnant patients or patients who cannot take appropriate contraceptive measures during treatment 9. anaphylaxis to any of the components of Ruxolitinib is known; 10. severe renal impairment, defined as serum creatinine > 2 mg/dL; 11. clinically significant or uncontrolled heart disease; 12. cholestatic disease, or unrelieved hepatic sinus obstruction syndrome/hepatic vein occlusion; 13. the researcher thinks that is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
the incidence of aGVHD;the incidence of virus reaction;neutral and platelet implantation time;

Secondary

MeasureTime frame
OS;RR;TRM;the incidence of cGVHD;Ruxolitinib side effect;

Countries

China

Contacts

Public ContactFu-xu Wang

the Second Hospital of Hebei Medical University

wfxhebmu@163.com+86 13931100360

Outcome results

None listed

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