CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two treatment options for adults with relapsed or refractory acute myeloid leukemia (AML), which means their cancer has returned or hasn’t responded to previous treatments. The study will look at how effective and safe a combination treatment called CLAG+VEN is compared to a standard treatment called CLAG. The trial is not yet recruiting participants, but when it does, it will involve adults aged 18 to 65 who have been diagnosed with AML according to specific medical guidelines.

To be eligible for the trial, participants must have experienced a relapse or shown resistance to traditional treatments, and they need to meet certain health criteria, such as having stable kidney and liver functions. Participants can expect to receive either of the treatment options and will be closely monitored throughout the study. Additionally, they will need to provide informed consent, meaning they understand the study's purpose and procedures. It’s important for potential participants to know that this trial does not include individuals with specific conditions, such as acute promyelocytic leukemia or certain other serious health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosed of AML according to the World Health Organization (WHO) classification.
• • 2. All patients should aged 18 to 65 years.
• • 3. Diagnosed of relapsed and refractory AML, according to The guidelines for diagnosis and treatment of relapse /refractory acute myelogenous leukemia in China（2023）
• • 4. Diagnostic criteria for relapsed AML: Leukemia cells reappear in the peripheral blood or primitive cells in the bone marrow ≥ 5% (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy) after CR, or leukemia cell infiltration appears outside the marrow.
• • 5. Diagnostic criteria for refractory AML: The newly diagnosed patients who failed to respond to two courses of standard treatment; Patients who relapsed within 12 months after consolidation intensive therapy; Patients who relapsed after 12 months and failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia.
• • 6. The score of Eastern Cooperative Oncology Group (ECOG) is 0-2.
• • 7. Renal function: creatinine clearance rate ≥ 30ml/min.
• • 8. Liver function: ALT\<5 times normal value, bilirubin\<3 times normal value.
• • 9. Predicted survival ≥ 3 months.
• • 10. Able to accept oral Venetoclax.
• • 11. Sign an informed consent form and be able to understand and follow the procedures required by this protocol.
• Exclusion Criteria:
• • 1. Diagnosed of acute promyelocytic leukemia (AML-M3)
• • 2. Patients with central nervous system (CNS) invasion.
• • 3. Cardiac function \< grade 2.
• • 4. Known human immunodeficiency virus (HIV) infection.
• • 5. Other clinically significant uncontrolled conditions, including but not limited to: a. uncontrolled or active systemic infections (viruses, bacteria, or fungi); b. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; c. Secondary tumors requiring active treatment.
• • 6. Allergy to experimental drugs.
• • 7. Pregnant and lactating women.
• • 8. Patients who ineligible for the study according to the investigator's assessment.