Trials / Unknown
UnknownNCT05262465
Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML
A Multicenter Clinical Study of Microtransplantation Combined With Azacytidine to Improve the Efficacy of Elderly Acute Myeloid Leukemia
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- guomei · Academic / Other
- Sex
- All
- Age
- 60 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.
Detailed description
Microtransplantation, which combines chemotherapy with adoptive infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC). Data from more than 70 elderly AML patients who received microtransplantation in Beijing showed that the remission rate and 2-year disease-free survival (DFS) reach 75-82% and 32-39% respectively, and microchimerisms (donor cells\<1%) were detected without GVHD. The results have been clinically validated in several other centers in China, United States and Australia. In this study, azacytidine, decitabine, BCL / 2 inhibitor and other drugs combined with micro transplantation were used in elderly AML in order to improve the curative effect. Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | microtransplantation, HLA-mismatched donor peripheral stem cell infusion | HLA-mismatched donor peripheral stem cell infusion |
| DRUG | Azacitidine | azacytidine 50-75mg/m2 |
| DRUG | Venetoclax | Venetoclax 100-300mg/d ×3d，400mg 4-28d |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2023-07-01
- Completion
- 2025-07-01
- First posted
- 2022-03-02
- Last updated
- 2022-03-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05262465. Inclusion in this directory is not an endorsement.