Clinical trial · Interventional
Cladribine Plus Homoharringtonine and Cytarabine Regimen (CHA) for de Novo 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia, Adult | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cladribine + homoharringtonine + cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- Intervention: CHA
- interventionNames
- Drug: cladribine + homoharringtonine + cytarabine
Primary outcomes (3)
- measure
- Complete response (CR) rate
- timeFrame
- At the end of Cycle 1 (each cycle is 28 days)
- description
- no signs of leukemia after treatment, fewer than 5% blasts in the BM, absolute neutrophil count (ANC) ≥ 1.0×109/L and platelet count ≥ 100×109/L and absence of the extramedullary tumor
- measure
- Overall Survival Rate
- timeFrame
- 2 years since enrollment
- description
- the ratio of cases alive to total enrolled cases within 2 years since enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available