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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Venetoclax
DrugGiven PO
Azacitidine (AZA)
DrugGiven SC
Daunorubicin
DrugGiven IV
Idarubicin（IDA）
DrugGiven IV
Cytarabine (Ara-C)
DrugGiven IV
GPBMC infusion
Biological/VaccineHLA-mismatched donor GPBMC infusion
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Participants fit for intensive therapyExperimental treatment 6 interventions
Group B: Participants unfit for intensive therapy but fit for lower intensity therapyExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Overall survival (OS)
OS is defined as the number of days from the date of initiation of treatment to the date of death.
Time frame
Measured up to 4 years after the last participant is enrolled2
Event-free Survival (EFS)
EFS is defined as the number of days from initiation of treatment to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause.
Time frame
Measured up to 4 years after the last participant is enrolledSecondary outcomes
1
Complete remission (CR) and complete remission with incomplete marrow recovery (CRi)
CR is defined as absolute neutrophil count \> 1 × 109/L, platelet count \> 100 × 109/L, red cell transfusion independence, and bone marrow with \< 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophil count \<= 1 × 109/L or platelet count \<= 100 × 109/L.
Time frame
Measured up to 2 years after the last participant is enrolled2
Partial remission (PR)
PR is defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow, peripheral blood neutrophil count \> 1 × 109/L, platelet count \> 100 × 109/L, red cell transfusion independence.
Time frame
Measured up to 2 years after the last participant is enrolled3
Non-relapse Mortality (NRM)
NRM is defined as the death without relapse.
Time frame
Measured up to 4 years after the last participant is enrolledSponsors and contacts
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Source ClinicalTrials.gov