NCT05906914CompletedPhase 2
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 · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 14 May 2023
- Start date
- 26 Oct 2022
- Primary completion date
- 11 Apr 2025
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05906914
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 65
- From 26 Oct 2022 to the primary completion date, 11 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosed or receiving treatment for other malignant tumors other than AML that are or are in need of treatment in the near future.
Other illness
- Patients with severe liver and kidney function, cardiopulmonary insufficiency.
- Uncontrolled or severe infection.
- Mental illness that may prevent subjects from completing treatment or informed consent.
Other
- Acute promyelocytic leukemia, myeloid sarcomas, accelerated and acute transformation of chronic myeloid leukemia.
Who the study is looking for
- The age is 18 to 59 years old, gender is not limited, race is not limited.
- Diagnosed as acute myeloid leukemia (AML) according to the diagnostic criteria of the World Health Organization (WHO) in 2016.
- No previous anti-acute leukemia therapy (including demethylation drugs for leukemia or myelodysplastic syndrome (MDS), except hydroxyurea and leukocytosis).
- Physical status \<= 2 according to eastern tumor cooperation group (ECOG).
- 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.
- The left ventricular ejection fraction\| (LVEF) measured by echocardiography was in the normal range (LVEF \> 50%).
- 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.
Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.