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)

IIT20220027C-R2

The goal of this clinical trial is to evaluate the response and safety of Cladribine plus Homoharringtonine and Cytarabine regimen (CHA) protocol in de novo acute myeloid leukemia with age \<60y. This is a prospective, single-armed mono-center based investigator-initiated trial. About 30 patients who meet the enrollment criteria with be treated with CHA as induction chemotherapy. The complete response rate, survival rate, recurrence rate, and treatment-related mortality with be observed.

2023-06-29

2024-12-31

2025-06-30

Recruiting

Early phase I

30

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-02-26