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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05660473
Phase
PHASE2
Status
Recruiting
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Conditions

  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Vincristine — DRUG
    Anti-tumor alkaloids
  • Daunorubicin — DRUG
    Anthracycline
  • Cyclophosphamide — DRUG
    Alkylating agent
  • Pegaspargase — DRUG
    Polyethylene glycol (PEG) conjugated to L-asparaginase
  • Prednisone — DRUG
    Glucocorticoids
  • Cytarabine — DRUG
    Pyrimidine antimetabolites
  • 6-mercaptopurine — DRUG
    Cell cycle-specific antitumor drug
  • Dexamethasone — DRUG
    Glucocorticoids
  • Methotrexate — DRUG
    Antifolate antineoplastic drug
  • Venetoclax — DRUG
    Selective inhibitor of B-cell lymphoma 2 (Bcl-2)

Study Details

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.

Key Dates

Start date
Aug 1, 2022
Status verified
May 2025
Primary completion
Dec 15, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pediatric-inspired Regimen Combined With Venetoclax
    Induction therapy is administered as follows：Vincristine (VCR) 1.4 mg/m2 (maximum dose 2 mg) IV on D1,8,1,5,22; Daunorubicin (DNR) 30 mg/m2/day IV on D1-3; Cyclophosphamide (CTX) 1200 mg/m2 IV on D1,15; Pegaspargase 2500u/m2 IM on D5; Prednisone 1 mg/kg/d PO on D1-14, 0.5 mg/kg/d PO on D15-28; Venetoclax 100 mg PO on D6，200 mg on D7, 400mg on D8-14, All patients underwent bone marrow aspiration on day 14 during induction. Patients with bone marrow blasts ≥10% on day 14 of induction received 7 additional days of Venetoclax on day 15-22. Consolidation therapy is a combination of multi-drug pediatric-inspired regimen chemotherapy and Venetoclax. Maintenance therapy consisted of a monthly VMMP regimen (vincristine, mercaptopurine, methotrexate, prednisone) continuing until 3 years for male and 2.5 years for female patients.

Primary Outcome Measure

MRD-negative complete remission rate measured by flow cytometry [ Time Frame: After induction (4 week) ]

Central Contacts

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