Combination treatment for blast phase CML using olverembatinib, venetoclax, and azacitidine
A Multicenter, Single-arm I/II Clinical Study of Olverembatinib Combined With Venetoclax and Azacitidine in in Blast Phase Ph Chromosome- Chronic Myeloid Leukemia
This study is testing a new combination of three medications to see if it can help people aged 15 and older with blast phase chronic myeloid leukemia feel better and improve their treatment options.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | olverembatinib, ponatinib, chemotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06757855 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of a combination therapy involving olverembatinib, venetoclax, and azacitidine in patients aged 15 years or older with blast phase chronic myeloid leukemia (CML). The study aims to determine the maximum tolerated dose of this combination during Phase I and assess the complete hematological response rate after two treatment courses in Phase II. Patients will receive the treatment for induction and consolidation, followed by potential allogeneic stem cell transplantation or continued therapy. The trial is designed to improve outcomes for patients who currently have limited treatment options.
Who should consider this trial
Good fit: Ideal candidates are patients aged 15 years or older with BCR::ABL1 positive blast-phase CML.
Not a fit: Patients with other forms of leukemia or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve response rates and survival outcomes for patients with blast phase CML.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in CML, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with t(9;22)(q34;q11)/BCR::ABL1 positive blast-phase CML who are aged 15 years or older, whether initially in the blast phase or progressing from the chronic phase, with no gender restriction. Blast phase criteria: Conforming to the 2022 WHO criteria for CML Blast phase: bone marrow or peripheral blood blast cells ≥ 20%; for diagnosis of acute lymphoblastic transformation, if the immature lymphoblasts (determined by immunophenotype) ≥ 5% according to the ICC 2022 criteria; blast cell aggregation in bone marrow or extramedullary tissues. 2. ECOG performance status score ≤ 2. 3. Major organ function assessment criteria: Total bilirubin \< 1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; serum creatinine \< 2×ULN; myocardial enzymes \< 2×ULN; serum amylase ≤ 1.5×ULN; left ventricular ejection fraction (LEF) within the normal range on echocardiography. 4. Men and women of reproductive potential agree and adopt effective contraceptive measures. 5. The informed consent form is signed by the patient himself/herself or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the control of the disease, the legal guardian or an immediate family member of the patient signs the informed consent form. Exclusion Criteria: 1. Before group entry, other systemic anti-cancer treatments for acute transformation were received (excluding single-agent TKI, hormone, or hydroxyurea for reducing tumor burden before group entry, and single-agent olverembatinib ≤ 14 days) 2. Myocardial infarction occurred within 12 months before enrollment in this study; other clinically significant cardiac diseases (such as unstable angina, congestive heart failure, uncontrollable hypertension, uncontrollable arrhythmia, etc.) 3. Uncontrolled active severe infection 4. Known positive serum HIV 5. Acute pancreatitis occurred within 1 year before study screening, or a history of chronic pancreatitis 6. Uncontrolled hypertriglyceridemia (triglycerides \> 450 mg/dL, i.e., 5.1 mmol/L) or hypercholesterolemia (total cholesterol (TC) ≥ 6.2 mmol/L) 7. Another malignancy diagnosed and treated within 5 years before diagnosis, or previously diagnosed with another malignancy with evidence of residual disease. Patients with non-melanoma skin cancer or any type of carcinoma in situ, if completely resected, should not be excluded 8. Pregnant or lactating women 9. Clinical manifestations of CNS leukemia or extramedullary infiltration 10. Uncontrolled diabetes, defined as glycated hemoglobin value \> 7.5%. Patients with previously existing but well-controlled diabetes need not be excluded 11. Mental illness that may prevent the subject from completing treatment or providing informed consent 12. Other conditions considered unsuitable for this study by the investigator
Where this trial is running
Tianjin, Tianjin Municipality
- Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Hui Wei, MD
- Email: weihui@ihcams.ac.cn
- Phone: 13132507161
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.