Combination treatment for blast phase CML using olverembatinib, venetoclax, and azacitidine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Hui Wei, MD
• Email: weihui@ihcams.ac.cn
• Phone: 13132507161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Olverembatinib monotherapy for adults with newly diagnosed chronic-phase CML

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• Treatment of Chronic Myeloid Leukemia with Olverembatinib

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.