Efficacy and Safety of Azacitidine Combined With Interferon in the Treatment of Post-transplant Recurrence
NCT ID: NCT04078399
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-08-28
2022-08-28
Brief Summary
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At the screening/baseline period, informed consent is obtained and the inclusion/exclusion criteria are checked. Plan to enroll 30 patients, and collect demographic data, medical history data, vital signs, physical examination, laboratory tests (hematuria, liver and kidney function; immune indicators: T cell subsets, Treg, etc.), pregnancy test for female patients And other necessary auxiliary inspections.
The time to start treatment is: a decrease in chimerism and/or minimal residual disease (MRD) after myeloid tumor allogeneic hematopoietic stem cell transplantation.
Detailed Description
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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 long-acting interferon Gebin). 1-1.5 million U / kg, once a week; or ordinary alpha-interferon, 200 acres / square meter / d (total ≥ 300MU / d), 5-7 days a week;
2. Start time of medication:
1 In the absence of immunosuppressive agents such as cyclosporine, the chimeric rate is decreased and/or MRD-positive: or in the case of immunosuppressive agents such as cyclosporine, the chimeric rate is fully chimeric and MRD-positive: A-interferon is first administered. Single-agent intervention, if there was no significant decrease in MRD for 2 consecutive courses (MRD decreased ≤ 50%), azacitidine combined with interferon intervention was started; 2 In the case of calmodulin immunosuppressant (cyclosporine or tacrolimus), the chimeric rate decreased and the MRD was negative, the immunosuppressant was rapidly reduced or discontinued, and the bone marrow was reviewed 2 weeks, if the chimeric rate did not rise. (decreased or stable), or after two consecutive immunosuppressive adjustments did not reach complete chimerism, start azacitidine combined with interferon intervention; (3) If cyclosporine or other immunosuppressive agents are applied before the start of the study, rapid reduction; dose reduction 1 / 4-1 / 2; if the chimeric rate increases or GVHD occurs, continue the immunosuppressant adjustment strategy; (4) Stop treatment: acute GVHD above II degree; patients are intolerant to the study protocol; basic regimen is ineffective after 2 courses of treatment (chimeric rate continues to decline or MRD continues to increase) or disease recurrence; transplant.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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patients with recurrence after allogeneic transplantat
One arm
Azacitidine combined with interferon preemptive treatment
Azacitidine combined with interferon preemptive therapy for prevention and treatment of recurrence of allogeneic transplantation of myeloid tumors (AML/MDS/MPN) in the blood system
Interventions
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Azacitidine combined with interferon preemptive treatment
Azacitidine combined with interferon preemptive therapy for prevention and treatment of recurrence of allogeneic transplantation of myeloid tumors (AML/MDS/MPN) in the blood system
Eligibility Criteria
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Inclusion Criteria
1. ≥ 14 years old, male or female;
2. Patients with allogeneic peripheral blood stem cell transplantation due to myeloid tumors of the blood system (AML/MDS/CML/MPN, etc.);
3. 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%;
4. Blood routine: neutrophils\>0.5×109/L, platelets\>25.0×109/L;
5. There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD;
6. Liver and kidney function: liver function (AST/ALT/TB) \<5 times normal upper limit; renal function (Cr) \< 2 times normal upper limit;
7. The patient must be able to understand and be willing to participate in the study and sign an informed consent form.
Exclusion Criteria
1. Recurrence after transplantation;
2. Patients who have not achieved complete remission after transplantation;
3. Implantation failed;
4. Pregnant or lactating women;
5. Have received other interventions or are receiving other research drugs before the study begins;
6. Patient blood routine: ANC \<0.5 × 109 / L or PLT \< 25 × 109 / L;
7. 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
8. People infected with HIV;
9. 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;
10. Those who are allergic to known azacitidine or interferon;
11. At the discretion of the investigator, other dangerous complications may result.
14 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Xianmin Song, MD
director
Principal Investigators
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Xianmin Song, M.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Xianmin Song
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHSYXY- aza-relapse-2019002
Identifier Type: -
Identifier Source: org_study_id