NCT06554626 Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL
| NCT ID | NCT06554626 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Precursor B-Cell Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-08-15 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study，we propose a treatment approach that combines Blinatumomab and Venetoclax sequenced with Inotuzumab Ozogamicin in B-ALL adults. Our study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Age ≥ 40 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 4. Expected survival time ≥ 3 months; 5. No organ dysfunction that would restrict the use of this protocol during the screening period; 6. Understand the study and sign the informed consent form. 7. 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 Criteria: 1. Patients with known central nervous system (CNS) involvement of ALL; 2. 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.); 3. Cardiac ultrasound LVEF \< 45%; 4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; 5. Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN; 6. Known HIV infection; 7. Conditions affecting the use of the study drug as assessed by the investigator; 8. Inability to understand or comply with the study protocol.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06554626 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Precursor B-Cell Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06554626 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06554626 currently recruiting?
Yes, NCT06554626 is actively recruiting participants. Contact the research team at jiej0503@163.com for enrollment information.
Where is the NCT06554626 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06554626 clinical trial?
NCT06554626 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 20 participants.
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