A Study of Olverembatinib Combined With Blinatumomab in the Treatment of Ph+ ALL

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jul 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults with Philadelphia chromosome-positive acute lymphoid leukemia (Ph+ ALL), a type of blood cancer. The treatment combines two medications: Olverembatinib, which patients will take every other day starting from when they are diagnosed, and Blinatumomab, which will be given through an IV for up to five cycles. The goal is to see if this combination can effectively help patients with this specific type of leukemia.

To participate in the trial, individuals must be at least 18 years old and have recently been diagnosed with Ph+ ALL, meaning they haven’t received any prior treatment with other medications or chemotherapy. They also need to meet certain health criteria, such as having acceptable organ function and not having uncontrolled infections or other serious health issues. While the trial is not yet recruiting participants, those who join can expect regular check-ups and monitoring throughout the study to ensure their safety and the effectiveness of the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
• • 2. Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy. Participants who only received preconditioning can be enrolled.
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.
• 4. Organ function as indicated by the following laboratory indicators must be met:
• • 1) Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN; 2) Total bilirubin≤1.5×ULN; 3) Serum creatinine≤1.5×ULN or 24-hour calculated creatinine clearance≥50mL/min when serum creatinine \>1.5×ULN; 4) Amylase≤1.5×ULN, lipase≤1.5×ULN; 5) Cardiac ejection fraction (EF) \> 50%, pulmonary artery systolic blood pressure ≤ 50mmHg; 6) QT interval corrected on electrocardiogram (ECG) evaluation: QTc≤450ms in males or ≤470ms in females; 7) PT, APTT and INR≤1.5×ULN.
• • 5. Willingness and ability to comply with study procedures and follow-up examination.
• Exclusion Criteria:
• • 1. Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCVpositive).
• • 2. Uncontrolled active infection.
• • 3. Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS.
• • 4. Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \> 140mmHg and/or diastolic blood pressure \> 90mmHg), or take medications that are known to cause QT interval prolongation. The patients with well controlled HBP can be considered to be included.
• • 5. Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is \>50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension.
• • 6. Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL.
• • 7. Patients who have any other malignant tumors that require treatment.
• • 8. Patients who have a history of pancreatitis or a history of alcohol abuse.
• • 9. Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol/L).
• • 10. Patients who are pregnant, planning to become pregnant or breastfeeding.
• • 11. Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug.
• • 12. Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures.
• • 13. Patients who suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.