Safety and Efficacy Clinical Trial
Official title:
A Prospective Multicenter, Single-arm Clinical Study of Anti-CD25 Monoclonal Antibody Combined With Ruxolitinib in the Treatment of Grade 3-4 Steroid-resistant Acute Graft-versus-host Disease
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 15, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 score=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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University | Huai'an Second People's Hospital, Soochow Hopes Hematonosis Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall response rate at day 28 | The primary endpoint is the overall response rate (ORR) at day 28 defined as proportion of patients demonstrating partial (PR) or complete response (CR) without requirement for additional systemic immunosuppressive therapy (IST) at day 28 after second-line treatment initiates. | day 28 | |
Secondary | ORR at d14/d56 | overall response rate at day 14/56 | day 14, day 56 | |
Secondary | Time to response | Time to response, defined as time from the day treatment initiates to the date of first documentation PR or CR. | through study completion(median 12 days according to previous study) | |
Secondary | Duration of response | Duration of response, assessed for responders only by calculating the time from first response to the date of first observation of aGvHD relapse/progression or the date of additional IST for GvHD. | through study completion, an average of 1year | |
Secondary | OS | Overall survival (OS) defined as time from the day treatment initiates to the date of death from any cause. | through study completion, an average of 1year | |
Secondary | EFS | Event-free survival (EFS) defined as the time from the day treatment initiates to the date of recurrence of underlying hematologic disease, graft failure or death due to any cause. | through study completion, an average of 1year | |
Secondary | incidence rate of secondary grade 3-4 liver aGVHD | incidence rate of secondary grade 3-4 liver aGVHD | through study completion, an average of 1 year | |
Secondary | incidence rated of chronic GVHD | incidence rated of chronic GVHD | through study completion, an average of 1 year |
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