Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with precursor B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer that can be aggressive and difficult to treat. The trial combines a medication called Blinatumomab with a lower dose of traditional chemotherapy to see if this combination is safe and effective in improving survival for patients. The goal is to find better treatment options for those diagnosed with this condition.

To participate in the trial, patients must be between the ages of 15 and 59 and have a confirmed diagnosis of B-ALL that does not involve the Philadelphia chromosome, which is a specific genetic marker. Participants should also be in good enough health to tolerate the treatment, meaning they should not have major organ problems or other serious health conditions. If eligible, participants can expect to receive the treatment under careful monitoring and will be required to provide informed consent, ensuring they understand the study and its requirements. This trial is currently recruiting new participants, and it aims to contribute to better outcomes for patients facing this challenging illness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Before enrollment, patients must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and be negative for Philadelphia chromosome. The diagnostic criteria refer to the 2022 WHO classification; 2. Age≥15 years， ≤59 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 4. Expected survival time ≥ 2 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. Unable to understand or comply with the study protocol.