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NCT06754267RecruitingPhase 2

Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph+ B-ALL

Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph-positive Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study

Source: ClinicalTrials.gov · Last updated 31 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Philadelphia chromosome positive (Ph+) ALL is defined as ALL with translocation between chromosomes 9 and 22. And t(9;22)(q34;q11) is the most common chromosomal abnormality in ALL. Before the emergence of TKI, the prognosis of Ph+ ALL was extremely poor, and the long-term survival rate was only 10%-35%. Ph+ ALL accounts for about 30% of adult ALL. In this study, the investigators propose a treatment approach that combines Venetoclax with Olverembatinib and Predinisone in Ph+ B-ALL adults. The study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
36 (estimated)
First submitted
18 Dec 2024
Start date
1 Dec 2024
Primary completion date
30 Dec 2025
Lead sponsor
First Affiliated Hospital of Zhejiang University
NCT number
NCT06754267

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 36
  • From 1 Dec 2024 to the primary completion date, 30 Dec 2025
  • 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.

Prior treatment

  • Subjects who have received systemic anti-leukemia treatment (including but not limited to TKI, radiotherapy or chemotherapy, except for the allowed pretreatment);

Other illness

  • Diseases with abnormal functions of organs such as lung, liver, and kidney that may limit the patient's participation in this trial (including but not limited to severe infection, uncontrolled diabetes, active tuberculosis, asthma, COPD, bronchiectasis, etc.);
  • History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
  • Known HIV infection;
  • Conditions affecting the use of the study drug as assessed by the investigator;

Lab values

  • Subjects with a history of myocardial infarction within 12 months, or have clinical manifestations of heart disease (including but not limited to unstable angina pectoris, congestive heart failure, uncontrolled hypertension and uncontrolled arrhythmia, etc.); left ventricular ejection fraction (LVEF) on echocardiography \<50%;
  • Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN;

Other

  • Accelerated phase or blast crisis of chronic myeloid leukemia;
  • Subjects with involvement of the central nervous system (CNS) or accompanied by extramedullary lesions;
  • Unable to understand or comply with the study protocol.

Who the study is looking for

  • Before enrollment, the patient must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and positive for Philadelphia chromosome (presence of t(9;22) and/or BCR::ABL1 positive and/or FISH positive). The diagnostic criteria refer to the 2022 WHO classification;
  • Age ≥ 18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
  • Expected survival time ≥ 3 months;
  • No organ dysfunction that would restrict the use of this protocol during the screening period;
  • Understand the study and sign the informed consent form.
  • Men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed effective by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.

Age in the registry: 18 years to - · 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
The First Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting

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