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NCT05660473RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 1 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
100 (estimated)
First submitted
13 Dec 2022
Start date
1 Aug 2022
Primary completion date
15 Dec 2027
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT05660473

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 100
  • From 1 Aug 2022 to the primary completion date, 15 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
  • History of pancreatitis
  • 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

Lab values

  • Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \>7.5%. Patients with preexisting, well-controlled diabetes are not excluded

Other

  • Burkitt lymphoma/leukemia
  • Acute Leukemia of Ambiguous Lineage
  • Female patients who are pregnant or breast feeding

Who the study is looking for

  • 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

Age in the registry: 14 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute of Hematology & Blood Diseases Hospital
Coordinator of this site? Confirm its status		TianjinChinaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.