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Multicenter clinical study for TKI combined with statins in the treatment of refractory generalized chronic graft-versus-host disease.

A multicenter, randomized, controlled and open clinical trial for TKI combined with statins in the treatment of refractory generalized chronic graft-versus-host disease.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026602
Enrollment
Unknown
Registered
2019-10-16
Start date
2019-10-18
Completion date
Unknown
Last updated
2019-10-21

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

Conditions

Graft Versus Host Disease

Interventions

Experimental group:TKI / TKI + statins were added. TKI dose: Imatinib 0.3g-0.4g/day or Dashatinib 50mg-100mg/day. Atorvastatin Calcium Tablets were treated with 10-40 mg/day according to its routine d
Control group:Conventional anti-cGVHD drugs, such as hormones, immunosuppressants, monoclonal antibodies, etc.

Sponsors

Medical Center of Hematology, Xinqiao Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) cGVHD occurs after allogeneic hematopoietic stem cell transplantation. According to the diagnostic criteria of cGVHD, it belongs to the patients with generalized GVHD; (2) between 18 and 60 years old; (3) Immunosuppressive agents are ineffective; (4) The life expectancy was longer than 3 month.

Exclusion criteria

Exclusion criteria: (1) those with effective immunosuppressive agents; (2) Patients who have participated in other clinical trials of cGVHD besides immunosuppressive agents.

Design outcomes

Primary

MeasureTime frame
The severity score of cGVHD;Target organ types of cGVHD;Changes of lymphocyte subsets;Recurrence rate of primary disease;Quality of life score, non-recurrence mortality;Flow cytometry analysis of Treg, Thl and Thil7 cell immune reconstitution after allogeneic hematopoietic stem cell transplantation and its relationship with cGVHD;

Secondary

MeasureTime frame
Adverse drug reactions;

Countries

China

Contacts

Public ContactKong Peiyan

Medical Center of Hematology, Xinqiao Hospital of Army Medical University

peiyankong@163.com+86 13228685528

Outcome results

None listed

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