Combining venetoclax with CAG for treating relapsed acute myeloid leukemia

Clinical Study of BCL-2 Inhibitor Venetoclax Combined With CAG in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia

This study is testing if a new combination of venetoclax and a specific treatment plan can help adults with relapsed acute myeloid leukemia feel better when other treatments haven't worked.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05918198 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of venetoclax in combination with the CAG regimen (Ara-C, Acla, and C C-GSF) for patients with refractory or relapsed acute myeloid leukemia (AML). Participants aged 18 to 75 will receive this treatment to determine its effectiveness in managing their condition. The study will assess both the safety profile and the therapeutic outcomes of this combination therapy in AML patients who have not responded to previous treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with relapsed or refractory acute myeloid leukemia.

Not a fit: Patients with acute myeloid leukemia who have not experienced relapse or refractory disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat acute myeloid leukemia.

How similar studies have performed: Previous studies have shown promising results with venetoclax in various hematological malignancies, suggesting potential success for this approach in AML.

Eligibility criteria

Inclusion Criteria:

* 18 years ≤ age ≤ 75 years, male and female are not limited.
* According to bone marrow morphology and immunophenotype, it was diagnosed as acute myeloid leukemia ( WHO 2016 diagnostic criteria).
* Morphological recurrence after complete remission (CR) (leukemic cells in the peripheral blood of CR patients or more than 5% of the blasts in the bone marrow or new pathological hematopoiesis or extramedullary leukemic cell infiltration) or acute myeloid leukemia patients who did not achieved CR after 1 cycle of chemotherapy.
* The ECOG (Eastern Cancer Cooperation Group of the United States) PS score is 0-1.
* The expected survival time is ≥ 12 weeks.
* Female patients of childbearing age need to undergo pregnancy examination before receiving chemotherapy, and must agree to take effective contraceptive measures during treatment.
* Subjects volunteered to participate, fully informed consent, signed an informed consent, and good compliance.

Exclusion Criteria:

* Other malignant hematological diseases that do not conform to the diagnosis of acute myeloid leukemia.
* Allergy to any drugs involved in the project.
* History of serious cardiovascular and cerebrovascular diseases: ① Congestive heart failure, unstable angina pectoris, myocardial infarction, stroke or poorly controlled arrhythmia with NYHA grade II or above occurred within 12 months before enrollment，LVEF (left ventricular ejection fraction)\<50% by color Doppler ultrasound，Corrected QT interval (QTc)\>480ms (calculated by Fridericia method, if the QTc is abnormal, it can be detected continuously for 3 times every 2 minutes, and the average value is taken)，Hypertension difficult to control by drugs (systolic blood pressure (BP) ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg) (based on the average of ≥ 3 BP readings obtained from ≥ 2 measurements)，Have had hypertensive crisis or hypertensive encephalopathy in the past.
* There are other obvious bleeding tendencies or evidence of major coagulation disorders: ①Hemoptysis of any reason occurred within 2 weeks before enrollment，② Thrombosis or embolism occurred within 6 months before enrollment，③ Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin therapy) be used within 2 weeks before enrollment④ Antiplatelet therapy is required.
* Abnormal liver function: total bilirubin\>3 mg/dL；Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 5 × Upper limit of normal value (ULN).
* Abnormal renal function: serum creatinine ≥ 1.5 × ULN, or the creatinine clearance rate (CrCl) calculated according to Cockroft-Gault formula is less than 60 mL/min (if the calculated CrCl is less than 60 mL/min, the researcher may ask to confirm the 24-hour CrCl, in this case, the subjects with 24-hour CrCl less than 60 mL/min should be excluded).
* Other serious diseases that may limit the patient's participation in this clinical trial (including but not limited to other malignant tumors, active infection, serious uncured wounds, active ulcers and untreated fractures, history of human immunodeficiency virus infection, and receiving allogeneic stem cells or solid organ transplantation).
* Cannot swallow pills, malabsorption syndrome or any condition that affects gastrointestinal absorption.
* Other clinical trials are being conducted.
* Unable to understand or cooperate to complete the research protocol.
* Pregnant and lactating patients
* Other situations that the researcher believes are not suitable for inclusion in the study.

Where this trial is running

Beijing, Beijing

• Peking University People's Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Wen-Jing Yu, M.D.

Conditions: Acute Myeloid Leukemia