Actively Recruiting
Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-12-19
20
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Reduced-dose Chemotherapy 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.
CONDITIONS
Official Title
Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and negative for Philadelphia chromosome according to 2022 WHO classification
- Age between 15 and 59 years
- ECOG performance status score of 0-2
- Expected survival time of at least 2 months
- No organ dysfunction that would restrict use of this treatment protocol
- Able to understand the study and sign informed consent
- Men and women of childbearing age (postmenopausal for at least 12 months considered infertile) and their partners agree to use effective contraception during treatment and for 12 months after last dose
You will not qualify if you...
- Known central nervous system involvement of acute lymphoblastic leukemia
- Abnormal heart, lung, liver, kidney, or other organ functions limiting participation, including severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis
- Cardiac ultrasound showing left ventricular ejection fraction below 45%
- History of other cancers within past 5 years, except localized thyroid cancer or in situ skin cancer
- Serum total bilirubin above 1.5 times upper limit of normal; ALT or AST above 2.5 times upper limit of normal; serum creatinine above 1.5 times upper limit of normal
- Known HIV infection
- Any condition affecting use of study drug as assessed by investigator
- Unable to understand or comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
J
Jie Jin, M.D.
CONTACT
C
Chenying Li, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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