Acute Myeloid Leukemia
Conditions
Brief summary
The goal of this observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).
Interventions
None listed
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed, morphologically documented AML based on the World Health Organization (WHO) 2016 classification. * Age ≥ 18 years and ≤ 59 years * Have been treat with the venetoclax in combination with standard induction and consolidation chemotherapy therapy, and in follow-up. * Be comprehensive of the research, and able to provide informed consent.
Exclusion criteria
* Diagnosis of acute promyelocytic leukemia (APL). * Prior treatment for AML, except for: leukapheresis, hydroxyurea, and growth factor/cytokine. * Unable to understand or participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | Assess up to 24 months. | DFS is calculated from the date of remission (inclusive of CR and CRi) to the date of relapse, death from any cause, or last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission (CR) rate | On Day 21 (window Day 21 to Day 35), a bone marrow aspirate specimen will be collected for morphology and pathology. | The rate of patient who get CR after induction therapy. |
| Rate of minimal residual disease (MRD) negativity | MRD will be tested after every cycle of therapy and during follow-up. | Percentage of patients achieving CR with no evidence of MRD after induction therapy, 1 cycle of consolidation therapy, and 4 cycles of consolidation therapy. MRD negativity is defined as \< 0.1% of CD45 expressing cells with the target immunophenotype, or as cycling threshold (Ct) ≥ 40 in ≥ 2 of 3 replicates by qPCR. |
| Overall survival (OS) | Assess up to 24 months. | OS is defined as the duration from initiation of induction treatment to the date of death from any cause or last follow-up. |
Countries
China
Outcome results
None listed