Status:
UNKNOWN
Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML
Lead Sponsor:
guomei
Conditions:
Adult Acute Myeloid Leukemia
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remissi...
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 t...
Eligibility Criteria
Inclusion
- Patients must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines.
- 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
- received operation 4 weeks before randomization
- 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.
- Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05262465
Start Date
July 1 2020
End Date
July 1 2025
Last Update
March 2 2022
Active Locations (1)
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1
The fifth medical center of PLA General Hospital
Beijing, Beijing Municipality, China