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Recruiting Phase 2

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

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About this study

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.

Condition
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Tested
Vincristine, Daunorubicin, Cyclophosphamide, Pegaspargase, Prednisone, Cytarabine, 6-mercaptopurine, Dexamethasone, Meth...
Sponsor
Institute of Hematology & Blood Diseases Hospital, China

Who can join

Age
14 to 60 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 14 years
  • Maximum age: 60 years
  • Study condition: Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • 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
  • Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（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 10

  • 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, potentially interfere with the completion of treatment

Where

1 site, 1 recruiting

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.