About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with malignant hematological diseases undergo haploid/sibling incomplete matching/unrelated donor transplantation;
Recurrence after transplantation (morphological, extramedullary, or molecular recurrence);
Plan to administer granulocyte colony-stimulating factor mobilization donor lymphocyte infusion (gDLI) for treatment;
No age, gender, or race restrictions;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
PDCy
DrugLow dose Cy 30 mg/kg/d was administered on the 3rd and 4th day after gDLI to prevent GVHD
Non Cy
DrugOral 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
1-year overall survival rate (OS)
1-year overall survival rate (OS)
1-year recurrence rate (CIR)
1-year recurrence rate (CIR)
1-year non recurrent mortality rate (NRM)
1-year non recurrent mortality rate (NRM)
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)
Locations
Sponsors and contacts
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