Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
Efficacy Evaluation: Follow up observation of the difference in efficacy and safety between two groups in preventing severe (III-IV) aGVHD.
Primary Exploratory Endpoint: Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI.
Secondary Exploratory Endpoints:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDCy group | Other | Low dose Cy 30 mg/kg/d was administered on the 3rd and 4th day after gDLI to prevent GVHD |
|
| Non Cy group | Other | Oral administration of low-dose CNI (CSA 25mg Q12H or FK506 0.25mg Q12H combined with azole fungal drugs) for 2 weeks to prevent GVHD at 0 days after gDLI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDCy | Drug | Low dose Cy 30 mg/kg/d was administered on the 3rd and 4th day after gDLI to prevent GVHD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI. | Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI. | Until the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year overall survival rate (OS) | 1-year overall survival rate (OS) | 1 year after the last patient was enrolled |
| 1-year recurrence rate (CIR) | 1-year recurrence rate (CIR) |
Not provided
Inclusion Criteria:
Subjects eligible for inclusion in this study must meet all of the following criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible for inclusion in this study:
Siblings of matched donor transplant;
Patients with other malignant tumors that require treatment;
There are active infections, such as hepatitis B, hepatitis C, tuberculosis, etc;
HIV serological reaction was positive;
Suffering from mental illness or other conditions that cannot comply with research, treatment, and monitoring requirements;
Pregnant patients or patients who are unable to take appropriate contraceptive measures during treatment;
Active heart disease is defined as one or more of the following:
Individuals who are allergic to any medication or component such as Cy, CNI, etc;
The researchers believe that it is not suitable for participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| erlie jiang, MD | Contact | +86-15122538106 | jiangerlie@ihcams.ac.cn |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Non Cy | Drug | Oral administration of low-dose CNI (CSA 25mg Q12H or FK506 0.25mg Q12H combined with azole fungal drugs) for 2 weeks to prevent GVHD at 0 days after gDLI |
|
| 1 year after the last patient was enrolled |
| 1-year non recurrent mortality rate (NRM) | 1-year non recurrent mortality rate (NRM) | 1 year after the last patient was enrolled |
| The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease (MRD) | The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease (MRD) | 1 year after the last patient was enrolled |
| The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups. | The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac | 1 year after the last patient was enrolled |