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Sirolimus combined with calcineurin inhibitors for steroid-ineffective/dependent cGVHD: multicenter, single-arm study

Sirolimus combined with calcineurin inhibitors for Steroid- ineffective/dependent cGVHD: multicenter, single-arm study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029921
Enrollment
Unknown
Registered
2020-02-16
Start date
2020-03-09
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

Steroid- ineffective/dependent cGVHD

Interventions

Case series:given sirolimus capsules combined with ciclosporin(CsA) or tacrolimus(FK506) capsules

Sponsors

The Hematology Department of Xinqiao Hospital, the Second Affiliated Hospital of The Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Clearly diagnosed as a hematological system disease; 2. Allogeneic hematopoietic stem cell transplantation has been performed; 3. cGVHD was definitely diagnosed; 4. Patients with chronic graft-versus-host disease after allogeneic hematopoietic stem cell ransplantation are dependent on hormones or hormone therapy fails; 5. Obtain informed consent from patients and their families, and voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Local restriction occurred after allogeneic hematopoietic stem cell transplantation; 2. No chronic graft-versus-host disease occurred; 3. The investigators concluded that patients with other serious underlying medical conditions were not eligible for inclusion (e.g., expected survival of less than 2 months); 4. Any other situation in which the researcher considers it inappropriate to enroll in the study.

Design outcomes

Primary

MeasureTime frame
Total response rates at 6 months and 1 year;

Secondary

MeasureTime frame
Overall survival;Progression free survival;Patients quality of life;Observe adverse reactions;

Countries

China

Contacts

Public ContactXi Zhang

The Hematology Department of Xinqiao Hospital, the Second Affiliated Hospital of The Army Medical University

zhangxxi@sina.com+86 13808310064

Outcome results

None listed

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