Venetoclax Combined With Olverembatinib and Predinisone
in Treating Ph-positive Precursor B Cell Acute Lymphoblastic Leukemia
A Phase II, Single-Arm, Multicenter Study
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-12-31
36
Participants Needed
1
Research Sites
160 weeks
Total Duration
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AI-Summary
Official Title
Who Can Participate
AI-Screening
Trial Site Locations
Research Team
How is the study designed?
Frequently Asked Questions
Published Results
AI-Summary
What this Trial Is About
Precursor B cell acute lymphoblastic leukemia (B-ALL) is a fast-growing type of leukemia with a high chance of relapse and poor long-term survival in adults. Philadelphia chromosome positive (Ph+) ALL, caused by a specific chromosome translocation, is a common abnormality in this disease and accounts for about 30% of adult ALL cases. This research is a phase II, open-label study aiming to explore the safety and effectiveness of combining Venetoclax with Olverembatinib and Predinisone to improve survival outcomes for adults with newly diagnosed Ph+ B-ALL.
Participants will receive a treatment regimen combining three drugs: Venetoclax, a BCL-2 inhibitor; Olverembatinib, a tyrosine kinase inhibitor; and Predinisone, a glucocorticoid. The study plans to enroll 36 participants to undergo this combination therapy in cycles lasting 28 days each, with the primary goal of assessing complete molecular response after three cycles.
Throughout the study, participants will be closely monitored for treatment response and safety. Researchers will evaluate the molecular response at the end of the third treatment cycle to determine the level of disease control. The study includes assessments of participants' health status and side effects, with informed consent and ongoing follow-up to ensure safety and gather detailed information about the treatment effects.
CONDITIONS
Official Title
Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph+ B-ALL
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Diagnosed with new precursor B-cell acute lymphoblastic leukemia positive for Philadelphia chromosome
Age 18 years or older
ECOG performance status score between 0 and 2
Expected survival time of at least 3 months
No organ dysfunction limiting use of study treatment
Able to understand the study and provide informed consent
Men and women of childbearing age must agree to use effective contraception during treatment and for 12 months after last dose
You will not qualify if you...
Accelerated phase or blast crisis of chronic myeloid leukemia
Involvement of central nervous system or extramedullary lesions
History of myocardial infarction within 12 months or heart disease such as unstable angina, heart failure, uncontrolled hypertension, arrhythmia, or LVEF below 50%
Severe lung, liver, or kidney disease limiting trial participation
Other malignancies within last 5 years except localized thyroid or in situ skin cancer
Elevated liver enzymes, bilirubin, or creatinine above specified limits
Known HIV infection
Conditions preventing use of study drugs
Unable to understand or follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
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Research Team
J
Jie Jin, M.D.
C
Chenying Li, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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Detection of MRD may predict the outcome of patients with Philadelphia chromosome-positive ALL treated with tyrosine kinase inhibitors plus chemotherapy.
Farhad Ravandi, Jeffrey L Jorgensen, Deborah A Thomas...
Prognostic factors for progression in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia in complete molecular response within 3 months of therapy with tyrosine kinase inhibitors.
Koji Sasaki, Hagop M Kantarjian, Nicholas J Short...
A new chemotherapy-free regimen of olverembatinib in combination with venetoclax and dexamethasone for newly diagnosed Ph+ acute lymphoblastic leukemia: Preliminary outcomes of a prospective study.
Long-term follow-up of a phase 2 study of chemotherapy plus dasatinib for the initial treatment of patients with Philadelphia chromosome-positive acute lymphoblastic leukemia.
Farhad Ravandi, Susan M O'Brien, Jorge E Cortes...
Final report of a phase II study of imatinib mesylate with hyper-CVAD for the front-line treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia.
UKALLXII/ECOG2993: addition of imatinib to a standard treatment regimen enhances long-term outcomes in Philadelphia positive acute lymphoblastic leukemia.