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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 recurrence after allogeneic transplantation of myeloid tumors (AML/MDS/MPN) in the blood system. Sex and safety.
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.
Treatment programs:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with recurrence after allogeneic transplantat | Experimental | One arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine combined with interferon preemptive treatment | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response rate | Treatment response rate after 6 months of pretreatment with azacitidine combined with interferon (primary response + secondary response) | 6months |
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Inclusion criteria:
Patients enrolled must meet the following criteria:
Exclusion criteria:
Possible subjects who meet any of the following criteria will be excluded from the trial:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianmin Song, M.D | Contact | 021-63240090 | shongxm@139.com | |
| Hongliang Fang, doctor | Contact | 021-58552006 | fanghongliang@dashengbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianmin Song, M.D | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xianmin Song | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 24, 2023 | |
| Reset | Apr 19, 2024 | |
| Release | Apr 24, 2024 |
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| Reset | Jun 11, 2024 |
| Release | Jun 12, 2024 |
| Reset | Jul 16, 2024 |
| Release | Jul 25, 2024 |
| Reset | Oct 22, 2024 |
| Release | Nov 17, 2024 |
| Reset | Jan 3, 2025 |
| Release | Jan 9, 2025 |
| Reset | Feb 3, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 24, 2023 | Apr 19, 2024 | |||
| Apr 24, 2024 | Jun 11, 2024 | |||
| Jun 12, 2024 | Jul 16, 2024 | |||
| Jul 25, 2024 | Oct 22, 2024 | |||
| Nov 17, 2024 | Jan 3, 2025 | |||
| Jan 9, 2025 | Feb 3, 2025 |