Status:
RECRUITING
Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Precursor B-Cell Lymphoblastic Leukemia
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
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. Traditional treatment regimens mainly include che...
Detailed Description
This is a prospective, single-arm, phase II and open-label study. A total of 20 Ph-negative B-ALL participants will be enrolled. The primary endpoint is 2-year event free survival(EFS). The induction...
Eligibility Criteria
Inclusion
- Before enrollment, a diagnosis of newly diagnosed precursor B-cell acute lymphoblastic leukemia with Philadelphia chromosome-negative must be confirmed. The diagnostic criteria refer to the 2022 WHO classification.
- Age ≥ 40 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.
Exclusion
- Patients with known central nervous system (CNS) involvement of ALL;
- Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.);
- Cardiac ultrasound LVEF \< 45%;
- History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
- Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN;
- Known HIV infection;
- Conditions affecting the use of the study drug as assessed by the investigator;
- Inability to understand or comply with the study protocol.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06554626
Start Date
August 15 2024
End Date
August 1 2027
Last Update
August 15 2024
Active Locations (1)
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1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003