NCT06250959RecruitingPhase 2
RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 Study
Source: ClinicalTrials.gov · Last updated 4 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 1 Feb 2024
- Start date
- 5 Feb 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Chen Suning
- NCT number
- NCT06250959
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 124
- From 5 Feb 2024 to the primary completion date, 31 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.
Other illness
- Mature B-cell leukemia/lymphoma, B-cell lymphoma, with 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
- 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 Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.