Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML
NCT ID: NCT05262465
Last Updated: 2022-03-02
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
300 participants
INTERVENTIONAL
2020-07-01
2025-07-01
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MST for unfit
Induction chemotherapy can use azacytidine combined with low-dose cytarabine, or azacytidine combined with BCL / 2 inhibitor, and infuse modified peripheral blood hematopoietic stem cells after chemotherapy.
Consolidation chemotherapy used azacytidine combined with low-dose cytarabine. After chemotherapy, modified peripheral blood hematopoietic stem cells were infused and repeated for 3 courses.
microtransplantation, HLA-mismatched donor peripheral stem cell infusion
HLA-mismatched donor peripheral stem cell infusion
Azacitidine
azacytidine 50-75mg/m2
Venetoclax
Venetoclax 100-300mg/d ×3d，400mg 4-28d
Interventions
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microtransplantation, HLA-mismatched donor peripheral stem cell infusion
HLA-mismatched donor peripheral stem cell infusion
Azacitidine
azacytidine 50-75mg/m2
Venetoclax
Venetoclax 100-300mg/d ×3d，400mg 4-28d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients have not been treated before.
* Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2.
* Patients must have a HLA mismatched donor who should be able to provide informed consent.
* All genders and races are eligible.
* ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min
* By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range.
* Donors must be able to safely undergo leukapheresis.
Exclusion Criteria
* acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
* active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
* occurred stroke or intracranial hemorrhage within 6 months before randomization.
* Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
* There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA).
* Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection
* Any situation processed by the PI that will be damaged to the patients safety.
* Patients and / or authorized family member refuse to sign the consent.
* attend other clinical researchers in 3 months.
60 Years
85 Years
ALL
No
Sponsors
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guomei
OTHER
Responsible Party
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guomei
director
Locations
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The fifth medical center of PLA General Hospital
Beijing, Beijing 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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MST-EAML2020
Identifier Type: -
Identifier Source: org_study_id
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