PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allo-HSCT

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05772273
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.
  • Donor lymphocyte infusion — BIOLOGICAL
    The 4 DLI doses (dose range: ±10%) of sib-matched donor HSCT patients were 1×10\^6/kg, 5×10\^6/kg, 1×10\^7/kg, 5×10\^7/kg; The 4 DLI doses (dose range: ±10%) of haploidentical or unrelated donor HSCT patients were 1×10\^5/kg, 5×10\^5/kg, 1×10\^6/kg, 5×10\^6/kg.
  • Camrelizumab — DRUG
    Camrelizumab 200mg Q2W for sib-matched donor HSCT patients, 100mg Q2W for haploidentical or unrelated donor HSCT patients.

Study Details

This study aims to evaluate the efficacy and safety of PD-1 inhibitor, Azacitidine, and low-dose DLI in AML relapse After allogeneic hematopoietic stem cell transplantation

Key Dates

Start date
Mar 15, 2023
Status verified
Nov 2025
Primary completion
Jul 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion
    Patients are given azacytidine for 7 days, followed by 4 DLI treatments on Days 10, 17, 24 and 31, with the dose of DLI and Camrelizumab adjusted according to the donor source. Camrelizumab infusions were given 3 hours after completion of the 1st and 3rd DLIs, respectively.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: ORR assessment is at day 39 (±2). ]

Central Contacts

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