Efficacy and Safety of Azacitidine Combined With Interferon in the Treatment of Post-transplant Recurrence
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 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.
Timeline
- Start
- 2019-08-28
- Primary completion
- 2022-08-28
- Completion
- 2022-08-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 32 mg/m2 | Subcutaneous |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 1e+06 iu/kg | — |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 1.5e+06 iu/kg | — |