Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML
ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing 302 Hospital
About this trial
The purpose of this study is to evaluate whether HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion with venetoclax-containing regimens (microtransplant, MST) could improve survival in adult patients with newly diagnosed acute myeloid leukemia (AML).
Eligibility criteria
Qualifiers
Age >=18 years, male or female, non-limited by race or ethnicity.
No prior anti-acute leukemia treatment (including hypomethylators for leukemia or MDS) with the exception that prior hydroxyurea and/or leukapheresis are permitted.
Confirmed acute myeloid leukemia in accordance with WHO criteria with a WBC count < 25 × 109/L.
Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )<= 3 × upper limit of normal(ULN), and total bilirubin <= 1.5 × ULN.
Disqualifiers
Acute promyelocytic leukemia, myeloid sarcoma, chronic myeloid leukemia accelerated phase and blast crisis.
Uncontrolled infection or hemorrhage.
Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.
Uncontrolled autoimmune disease or requiring immunosuppression treatment.
Trial design
Treatments tested in this trial
- Venetoclax
- Azacitidine (AZA)
- Daunorubicin
- Idarubicin（IDA）
- Cytarabine (Ara-C)
- GPBMC infusion
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov