NCT05557110CompletedPhase 2
Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL
A Multicenter, Single-arm, Open-end Study of Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Philadelphia Chromosome Negative Acute B Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects. In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and treated with reduced-intensity chemotherapy followed by Blinatumomab as the basis of induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated in newly diagnosed non-elderly PH-B-ALL patients during induction therapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 16 Sept 2022
- Start date
- 8 Sept 2022
- Primary completion date
- 5 Jan 2024
- Lead sponsor
- Chen Suning
- NCT number
- NCT05557110
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 35
- From 8 Sept 2022 to the primary completion date, 5 Jan 2024
- 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
- Mature B-cell leukemia/lymphoma, B-cell lymphoma, isolated extramedullary disease
- HIV infection
- HBV-DNA or HCV-RNA positive
- Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator
Other
- Ph+ (BCR-ABL1 positive) ALL and known ABL class Ph-Like ALL
- T cells ALL
- Acute mixed-cell leukemia
- Central nervous system leukemia
- Pregnant or breastfeeding patients
- The study patient was refused enrollment
Who the study is looking for
- Age 15-65
- Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
- Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days)
- ECOG score 0-3
- Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)
- Renal function: endogenous creatinine clearance ≧30ml/min
- Patients must be able to understand and willing to participate in the study and must sign the informed consent form.
Age in the registry: 15 years to 65 years · 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 of Soochow University, Jiangsu Institute of Hematology Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.