Status:
UNKNOWN
Efficacy and Safety of Azacitidine Combined With Interferon in the Treatment of Post-transplant Recurrence
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
HSCT
Efficacy and Safety
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
This study is a single-center, one-arm, prospective, phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with interferon in the prevention of recu...
Detailed Description
Treatment programs: 1. Basic protocol: Azacitidine is administered subcutaneously at 32 mg/m2/d for 5 consecutive days; α-interferon treatment started on day 8 for 3 weeks; 4-6 weeks/treatment with l...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients enrolled must meet the following criteria:
- ≥ 14 years old, male or female;
- Patients with allogeneic peripheral blood stem cell transplantation due to myeloid tumors of the blood system (AML/MDS/CML/MPN, etc.);
- Recurrence trend evaluation criteria: the proportion of bone marrow blast cells \<5%; flow cell MRD ≥ 0.01% and interval 2 consecutive times 2 times; fusion gene interval 2 weeks at least 2 consecutive positive and rising trend or from negative to positive; Bone marrow WT1 levels increased dynamically and were greater than 0.6%; chimeric rate (STR) decreased by \>5% (STR \<90%) or XY-FISH donor chimerism decreased by \>0.5%;
- Blood routine: neutrophils\>0.5×109/L, platelets\>25.0×109/L;
- There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD;
- Liver and kidney function: liver function (AST/ALT/TB) \<5 times normal upper limit; renal function (Cr) \< 2 times normal upper limit;
- The patient must be able to understand and be willing to participate in the study and sign an informed consent form.
- Exclusion criteria:
- Possible subjects who meet any of the following criteria will be excluded from the trial:
- Recurrence after transplantation;
- Patients who have not achieved complete remission after transplantation;
- Implantation failed;
- Pregnant or lactating women;
- Have received other interventions or are receiving other research drugs before the study begins;
- Patient blood routine: ANC \<0.5 × 109 / L or PLT \< 25 × 109 / L;
- There are active uncontrolled infections: hemodynamic instability associated with infection, or new signs or signs of infection, or new infections in imaging, persistent fever with asympto or signs cannot be ruled out Infected person
- People infected with HIV;
- Active hepatitis B (HBV), active hepatitis C (HCV) requires antiviral therapy; patients with HBV activation risk refer to patients with hepatitis B surface antigen positive or core antibody positive patients who do not receive anti-HBV treatment;
- Those who are allergic to known azacitidine or interferon;
- At the discretion of the investigator, other dangerous complications may result.
Exclusion
Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 28 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04078399
Start Date
August 28 2019
End Date
August 28 2022
Last Update
October 27 2020
Active Locations (1)
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1
Xianmin Song
Shanghai, Shanghai Municipality, China, 200080