Combination chemotherapy for newly diagnosed acute myeloid leukemia

A Monocenter Prospective Single Arm Study of Cladribine Plus Homoharringtonine and Cytarabine Regimen (CHA) for Induced Therapy in Adults de Novo Acute Myeloid Leukemia (Non-M3)

This study is testing a new combination of chemotherapy drugs to see if it can help adults under 60 with newly diagnosed acute myeloid leukemia feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05906914 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a new chemotherapy regimen called CHA, which includes cladribine, homoharringtonine, and cytarabine, for treating adults with de novo acute myeloid leukemia (AML) aged under 60. The study is a prospective, single-armed trial that aims to enroll about 30 patients who will receive the CHA regimen as induction chemotherapy. The trial will monitor complete response rates, survival rates, recurrence rates, and treatment-related mortality. Patients will be stratified based on their prognostic risk and may receive additional treatments based on their response to the initial chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 59 years who have been newly diagnosed with acute myeloid leukemia and have not received prior treatment.

Not a fit: Patients over the age of 59 or those with previous anti-leukemia therapy may not benefit from this study.

Why it matters

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

How similar studies have performed: While this approach is novel, similar chemotherapy regimens have shown promise in treating acute myeloid leukemia in other studies.

Eligibility criteria

Inclusion Criteria:

1. The age is 18 to 59 years old, gender is not limited, race is not limited.
2. Diagnosed as acute myeloid leukemia (AML) according to the diagnostic criteria of the World Health Organization (WHO) in 2016.
3. No previous anti-acute leukemia therapy (including demethylation drugs for leukemia or myelodysplastic syndrome (MDS), except hydroxyurea and leukocytosis).
4. Physical status \<= 2 according to eastern tumor cooperation group (ECOG).
5. Within 21 days before random grouping and at baseline, biochemical indicators must be within the following limits: Glutamic pyruvic transaminase (ALT) and glutamic oxaloacetic transaminase (AST) \<= 3 × normal upper limit (ULN); total bilirubin \<= 3 × ULN; serum creatinine \<= 2 × ULN or serum creatinine clearance rate (CrCl)\>= 40mL/min.
6. The left ventricular ejection fraction\| (LVEF) measured by echocardiography was in the normal range (LVEF \> 50%).
7. Each patient (or his or her legal representative) must sign an informed consent form (ICF), indicating that he / she understands the purpose and procedures of the study and is willing to participate in the study.

Exclusion Criteria:

1. Diagnosed or receiving treatment for other malignant tumors other than AML that are or are in need of treatment in the near future.
2. Acute promyelocytic leukemia, myeloid sarcomas, accelerated and acute transformation of chronic myeloid leukemia.
3. Patients with severe liver and kidney function, cardiopulmonary insufficiency.
4. Uncontrolled or severe infection.
5. Mental illness that may prevent subjects from completing treatment or informed consent.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jie Sun — Zhejiang University
• Study coordinator: Zhen Cai, MD, Ph.D

Conditions Acute Myeloid Leukemia, Adult