About this trial
The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.
Eligibility criteria
Qualifiers
De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification
Age: 14 -60 years
Male or female
ECOG Performance Status 0-2
Disqualifiers
Burkitt lymphoma/leukemia
Acute Leukemia of Ambiguous Lineage
Female patients who are pregnant or breast feeding
Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
Trial design
Treatments tested in this trial
- Vincristine
- Daunorubicin
- Cyclophosphamide
- Pegaspargase
- Prednisone
- Cytarabine
- 6-mercaptopurine
- Dexamethasone
- Methotrexate
- Venetoclax