NCT06554626RecruitingPhase 2
Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL
The Regimen of Blinatumomab and Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating Precursor B Cell Acute Lymphoblastic Leukemia: A Phase II, Single Arm and Multicenter Study
Source: ClinicalTrials.gov · Last updated 15 Aug 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. 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 6 Aug 2024
- Start date
- 15 Aug 2024
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT06554626
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 15 Aug 2024 to the primary completion date, 1 Aug 2026
- 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
- 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.);
- 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
- Cardiac ultrasound LVEF \< 45%;
- Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN;
Other
- Patients with known central nervous system (CNS) involvement of ALL;
- Inability to understand or comply with the study protocol.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
Related publications
- Immunotherapy in B-Cell Acute Lymphoblastic Leukemia.J Natl Compr Canc Netw · 2025 · PMID 41671463
This page is information, not medical advice. Discuss any trial with your doctor.