Acute Myeloid Leukemia
Conditions
Keywords
venetoclax, microtransplant, microtransplantation
Brief summary
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).
Interventions
DRUGVenetoclax
Given PO
DRUGAzacitidine (AZA)
Given SC
DRUGDaunorubicin
Given IV
DRUGIdarubicin（IDA）
Given IV
Given IV
BIOLOGICALGPBMC infusion
HLA-mismatched donor GPBMC infusion
Sponsors
Beijing 302 Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Adequate renal function including serum creatinine \<= 2 × ULN or CrCl\>= 40mL/min. * LVEF measured by echocardiogram is within the normal range (LVEF \> 50%). * The subject must have one donor who is \>= 18 years old and HLA matched at 0-7/10 loci (i.e., at least 3 HLA loci must be mismatched). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form. * Each subject (or his/her legal representatives) must sign the Informed Consent Form (ICF), indicating that he/she understands the purpose and procedures of research, and is willing to participate in research. * Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form.
Exclusion criteria
* 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. * History of severe blood infusion reaction. * Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. * Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements. * Any major surgery within 4 weeks before enrollment. * Life-threatening illness other than AML or uncontrolled intercurrent illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Measured up to 4 years after the last participant is enrolled | OS is defined as the number of days from the date of initiation of treatment to the date of death. |
| Event-free Survival (EFS) | Measured up to 4 years after the last participant is enrolled | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission (CR) and complete remission with incomplete marrow recovery (CRi) | Measured up to 2 years after the last participant is enrolled | 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. |
| Partial remission (PR) | Measured up to 2 years after the last participant is enrolled | 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. |
| Non-relapse Mortality (NRM) | Measured up to 4 years after the last participant is enrolled | NRM is defined as the death without relapse. |
Countries
China
Contacts
Primary ContactBo Cai, MD
Backup ContactYangyang Lei, MD
Outcome results
None listed