Comparing two chemotherapy regimens for elderly patients with acute myeloid leukemia

HAV Versus DAV/IAV Induction Regimen in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy: a Multicenter, Randomized, Controlled Clinical Trial

This study is testing two different chemotherapy treatments to see which one helps older patients with acute myeloid leukemia feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 60 Years to 75 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06744556 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, prospective, randomized, and controlled study aimed at enrolling elderly patients diagnosed with acute myeloid leukemia (AML) who are suitable for intensive chemotherapy. Participants will be randomly assigned to receive either the DAV/IAV or HAV induction therapy regimens. Following induction, patients achieving complete remission will undergo consolidation therapy with intermediate-dose cytarabine, followed by maintenance therapy. The study aims to evaluate the efficacy of these regimens in improving outcomes for elderly AML patients.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly patients aged 60 to 75 years diagnosed with AML who are eligible for intensive chemotherapy.

Not a fit: Patients with AML who are younger than 60 years or those who are not suitable for intensive chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve survival rates and treatment outcomes for elderly patients with acute myeloid leukemia.

How similar studies have performed: Other studies have shown promising results with similar chemotherapy regimens in elderly AML patients, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Conforming to the diagnostic criteria of AML or MDS/AML by WHO (2022) or ICC.
2. Age ≥ 60 years and ≤ 75 years, regardless of gender.
3. The performance status assessment of the Eastern Cooperative Oncology Group (ECOG-PS) is 0 - 2.
4. Meeting the requirements of the following laboratory examination indicators (performed within 7 days before treatment):

1) Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group; 2) AST and ALT ≤ 2.5 times the upper limit of normal for the same age group; 3) Serum creatinine \< 2 times the upper limit of normal for the same age group; 4) Cardiac enzymes \< 2 times the upper limit of normal for the same age group; 5) The cardiac ejection fraction determined by echocardiography (ECHO) \> 50%. The informed consent form must be signed before the initiation of all specific research procedures. It should be 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 treatment of the disease, the informed consent form should be signed by the legal guardian or an immediate family member of the patient.

Exclusion Criteria:

1. Acute promyelocytic leukemia accompanied by the PML-RARA fusion gene
2. Acute myeloid leukemia accompanied by the RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
3. Acute myeloid leukemia accompanied by the BCR-ABL fusion gene
4. Retreated patients (referring to those who have previously undergone induction chemotherapy but can receive hydroxyurea for cytoreduction).
5. Patients concurrently suffering from malignant tumors in other organs (requiring treatment).
6. Active cardiac diseases, defined as one or more of the following:

1) Uncontrolled or symptomatic angina pectoris history; 2) Myocardial infarction less than 6 months from the time of enrollment in the study; 3) History of arrhythmias requiring drug treatment or with severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\> NYHA Grade 2);

7. Severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis).

8. Those considered ineligible for enrollment by the researcher.

Where this trial is running

Tianjin, Tianjin

• Blood Diseases Hospital — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Hui Wei, MD

Conditions AML; Elderly Patients