Overview

Basiliximab Combined With Ruxolitinib as Second-line Treatment of Grade 3-4 Steroid-resistant aGVHD

Status:
Recruiting
Trial end date:
2022-12-15
Target enrollment:
0
Participant gender:
All
Summary
Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The recognized first-line treatment for grade 3-4 aGVHD is systemic glucocorticoid. However, there is no recognized second-line treatment for grade 3-4 steroid-resistant aGVHD (SR-aGVHD). The investigators try to observe the efficacy and safety of early application of anti-CD25 monoclonal antibody(basiliximab) combined with ruxotilinib in the treatment of severe SR-aGVHD.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborators:
Huai'an Second People's Hospital
Soochow Hopes Hematonosis Hospital
Treatments:
Basiliximab
Criteria
Inclusion Criteria:

- Clinical diagnosis of primary grade 3-4(according to MAGIC criteria) steroid-resistant
acute graft-versus-host disease(progression after 3 days or lack of improvement after
5 days of systemic 1.5-2 mg/kg steroids).

- Age 18-65.

- ECOG scoreā‰¤3.

- Must be able to understand and willing to participate in the study and sign the
informed consent.

Exclusion Criteria:

- Refractory/secondary graft-versus-host disease.

- Severe complications such as myocardial infarction, chronic cardiac insufficiency,
hepatic failure, renal insufficiency, etc.

- Clinically uncontrolled active infections.

- Other Malignant tumors with progression.

- Ecg: QT interval > 450 ms.

- Allergic to arsenic agent.

- Pregnant or lactating women.

- Expected survival <60 days.

- Undergoing other drug clinical trials.