CAV Regimen for R/R AML

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Dec 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called the CAV regimen, which combines three medications—cladribine, low-dose cytarabine, and venetoclax—to see how well it works and how safe it is for patients with relapsed or refractory acute myeloid leukemia (R/R AML). R/R AML means that the leukemia has either come back after treatment or did not respond to initial treatments. The trial is currently looking for participants aged 16 to 65 who have been diagnosed with this condition and meet specific health criteria.

To be eligible, participants should not have serious heart, lung, liver, or kidney problems and must be able to understand and agree to take part in the study. Those who join the trial can expect to receive the CAV treatment and will be closely monitored by doctors for any side effects or changes in their condition. It’s important to note that certain individuals, like pregnant women or those with specific health issues, will not be able to participate in this study. If you or someone you know has R/R AML, this trial may be an option worth discussing with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 16-65 years old.
• • 2. Diagnosed with R/R AML.
• 3. Patients with AML must meet one of the following criteria, A or B: A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) \< 50% and \> 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML disease was defined as follows:
• • (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.
• • 4. ECOG performance status score less than 2. 5. Expected survival time ≥12 weeks. 6. Without serious heart, lung, liver, or kidney dysfunction. 7. Able to understand and provide informed consent.
• Exclusion Criteria:
• • 1. Patients who are allergic to the study drug or drugs with similar chemical structures.
• • 2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
• • 3. Active infection.
• • 4. Active bleeding.
• • 5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
• • 6. Patients with mental disorders or other conditions.
• • 7. Liver function abnormalities (total bilirubin \> 1.5 times of the upper limit of the normal range, ALT/AST \> 2.5 times of the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal dysfunction (Ccr\<50ml/h).
• • 8. Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
• • 9. Patients who relapsed after allogeneic hematopoietic stem cell transplantation.
• • 10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.
• • 11. Patients who have received organ transplants.
• • 12. Patients not suitable for the study according to the investigator's assessment.