Combining Venetoclax with Intensive Therapy for Acute Myeloid Leukemia Patients
A Single-Center Prospective Cohort Study to Evaluate the Efficacy and Safety of Intensifying Treatment with Venetoclax in Patients with Newly Diagnosed Acute Myeloid Leukemia (non-APL) and Exhibiting Lower Early Peripheral Blast Clearance Rate After Standard Intensive Induction Chemotherapy
This study is testing if adding a drug called Venetoclax to standard chemotherapy can help newly diagnosed acute myeloid leukemia patients who aren't responding well to their initial treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 83 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT06643962 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study evaluates the efficacy and safety of intensifying treatment with Venetoclax alongside the standard 3+7 chemotherapy regimen in newly diagnosed acute myeloid leukemia (AML) patients who show lower early peripheral blast clearance rates after initial treatment. Participants aged 18 to 70 years, who are treatment-naïve and fit for intensive chemotherapy, will be enrolled based on specific eligibility criteria, including the presence of leukemia-associated immunophenotype cells. The study aims to determine if the addition of Venetoclax can improve outcomes for patients with lower blast clearance rates after standard induction therapy.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed AML patients aged 18 to 70 years, except those with acute promyelocytic leukemia, who are eligible for intensive chemotherapy.
Not a fit: Patients who have received prior chemotherapy for AML or those with acute promyelocytic leukemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with acute myeloid leukemia who have a poor early response to standard therapy.
How similar studies have performed: While the use of Venetoclax in AML is being explored, this specific combination with intensive chemotherapy for patients with lower early peripheral blast clearance is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Newly diagnosed AML, except for the APL subtype, according to the 2022 World Health Organization classification (WHO 2022 criteria)
* Age ≥18 years and ≤70 years
* Eligible for intensive chemotherapy
* No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \[WBC\] counts\>25x10\^9/L)
* Eastern Cooperative Oncology Group (ECOG) performance status≤2
* Adequate renal function is defined as:
* Serum creatinine≤2.0×upper limit of normal (ULN)
* Creatinine clearance (CrCl)\>30 mL/min calculated by the Cockcroft-Gault equation.
* Adequate hepatic and heart function is defined as:
* Serum total bilirubin≤1.5×ULN unless considered due to Gilbert's disease, or leukemic involvement
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP)≤2.5×ULN, unless considered due to leukemic involvement
* Myocardial enzyme\<2.0×ULN
* Left ventricular ejection fraction is within the normal range by measure of echocardiogram (ECHO)
* Signed a written informed consent form (ICF)
* Female participants who are of non-reproductive potential (i.e., post-menopausal by history of no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female participants of childbearing potential must have a negative serum pregnancy test upon study entry
Exclusion Criteria:
* AML with BCR-ABL1 or myeloid blast crisis of CML
* Participants who have received prior treatment for AML with chemotherapy, hypomethylating agents, or venetoclax
* Participants who are ineligible for intensive induction chemotherapy:
* ≧71 years old OR
* ≧18 to 70 years old and fulfill at least one criterion associated with lack of fitness for intensive induction chemotherapy:
* ECOG PS of 2-3
* Cardiac history of CHF requiring treatment or Ejection Fraction ≦50% or chronic stable angina
* Diffusing capacity of the lungs for carbon monoxide (DLCO)≦65% or the forced expiratory volume in one second (FEVI) ≦65%
* Participants with a prior history of MDS, MPN, or MDS/MPN
* Participants with other concurrent malignant tumors on treatment, except for:
* Malignancy treated with curative intent and with no known active disease present for ≧3 years
* Adequately treated non-melanoma skin cancer or lentigo maligna without current evidence of disease
* Adequately treated carcinoma in situ without current evidence of disease
* Localized prostate cancer with a Gleason score of 6 or less
* Pregnant or lactating women
* Active heart disease is defined as any one of the following:
* Uncontrolled or symptomatic angina pectoris
* A myocardial infarction six months before enrolled
* Arrhythmia needs medication or with severe clinical symptoms
* Uncontrolled or symptomatic congestive heart failure (New York Hear Association \[NYHA\] classification\> grade 2)
* Participants with an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
* Participants with an active viral infection caused by HIV, hepatitis B, or hepatitis C virus that cannot be controlled by treatment
* Participants with evidence of central nervous system leukemia before the study treatment
* Participants with epilepsy which needs drug treatment, dementia, or other abnormal mental states that prevent understanding or following the protocol
* Conditions that restrict the intake or absorption of orally administered drugs
Where this trial is running
Nantong, Jiangsu
- Affiliated hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Yingxin Sun, Dr
- Email: syx20194132088@163.com
- Phone: +86-13646249970
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.