Combining olverembatinib with chemotherapy and venetoclax for treating new cases of Ph+ ALL
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia: A Prospective, Single-arm, Single-center Clinical Trial
This study is testing a new combination of a drug called olverembatinib with chemotherapy and venetoclax to see if it helps people with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | ponatinib, Olverembatinib, chemotherapy |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT05594784 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of olverembatinib, a third-generation TKI, in combination with reduced-intensity chemotherapy and venetoclax for patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The study aims to leverage the improved outcomes associated with olverembatinib and venetoclax, which have shown promise in previous studies for relapsed/refractory cases. Participants will be closely monitored for treatment responses and potential side effects throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 14 years or older with newly diagnosed Ph+ ALL.
Not a fit: Patients with prior treatment for Ph+ ALL or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve outcomes for patients with newly diagnosed Ph+ ALL.
How similar studies have performed: Previous studies have shown promising results with similar combinations of TKIs and venetoclax in relapsed/refractory Ph+ ALL, suggesting potential for success in this new patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients aged 14 years or older 2. Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL positive and/ or FISH positive) acute lymphoblastic leukemia; Patients will be diagnosed according to morphologic,immunologic, cytogenetic and molecular(MICM) criteria, including bone marrow morphology, immunophenotype, cytogenetic and molecular genetic (BCR/ABL gene, qualitative and quantitative analysis) examination 3. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 4. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%; 5. Subject has provided written informed consent prior to any screening procedure Exclusion Criteria: 1. Lymphoid blast crisis of chronic myelocytic leukemia (CML) 2. Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and/or radiotherapy, except for appropriate pre-treatment) 3. Clinical manifestations of CNS or extramedullary involvement with ALL 4. Patients with a history of myocardial infarction within 12 months or clinically significant cardiac disorders disease (e.g., unstable angina, congestive heart failure, uncontrollable hypertension, uncontrollable arrhythmia, etc.) 5. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment 6. Known HIV seropositivity 7. History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis 8. Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL) 9. Female patients who are pregnant or breast feeding 10. Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \>7.5%. Patients with preexisting, well-controlled diabetes are not excluded 11. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
Where this trial is running
Tianjin
- Institute of Hematology & Blood Diseases Hospital — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Jianxiang Wang, Dr — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Jianxiang Wang, Dr
- Email: wangjx@ihcams.ac.cn
- Phone: 86-22-23909120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.