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

Last updated: March 1, 2023
Sponsor: Institute of Hematology & Blood Diseases Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT05660473
IIT2022052-EC-1
  • Ages 14-60
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by thebone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biologyaccording to WHO classification
  • Age: 14 -60 years
  • Male or female
  • ECOG Performance Status 0-2
  • Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit ofnormal(ULN); serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present;Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN;Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%;
  • Subject has provided written informed consent prior to any screening procedure

Exclusion

Exclusion Criteria:

  • 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
  • History of pancreatitis
  • Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of >7.5%. Patients with preexisting, well-controlled diabetes are not excluded
  • History of active gastrointestinal bleeding within the last 6 months
  • History of arterial/venous thrombosis within the last 6 months
  • Known HIV seropositivity
  • Any serious psychiatric illness that could, in the investigator's opinion, potentiallyinterfere with the completion of treatment

Study Design

Total Participants: 100
Study Start date:
October 31, 2022
Estimated Completion Date:
December 30, 2027

Connect with a study center

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020
    China

    Active - Recruiting

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