Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-60
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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

Treatment groups

100 Participants
are divided into 1 treatment group