Completed

CHACladribine, Homoharringtonine and Cytarabine (CHA) Regimen for Adult Acute Myeloid Leukemia Remission

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Study Aim

This study aims to evaluate the effectiveness of the Cladribine, Homoharringtonine and Cytarabine (CHA) regimen in achieving remission in adult patients with Acute Myeloid Leukemia, focusing on complete response rate, disease-free survival, and overall survival within 2 years of enrollment.

What is being tested

cladribine + homoharringtonine + cytarabine

Drug
Who is being recruted

Hematologic Diseases+4

+ Hemic and Lymphatic Diseases

+ Leukemia

From 18 to 59 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2022
See protocol details

Summary

Principal SponsorFirst Affiliated Hospital of Zhejiang University
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 26, 2022

Actual date on which the first participant was enrolled.

This study focuses on a new chemotherapy regimen called CHA, which is a combination of cladribine, homoharringtonine, and cytarabine. The purpose of this regimen is to induce remission in adults diagnosed with a type of blood cancer known as acute myeloid leukemia. The study aims to evaluate the effectiveness and safety of this new treatment approach. The importance of this study lies in its potential to improve the care and outcomes for patients with this specific form of leukemia. Participants in this study will receive the CHA regimen, with specific dosages and durations for each drug. Treatment response will be assessed after each cycle, and further treatment will be determined based on these responses. If a patient achieves more than a partial remission in the first course, the CHA regimen is repeated. If a partial response is not achieved in the first course, or a complete response is not achieved in the second course, the patient will be withdrawn from the study. The study measures the results by evaluating bone marrow samples and assessing the response according to the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. Potential risks and benefits will be evaluated as part of the study.

Official TitleA 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)
NCT05906914
Principal SponsorFirst Affiliated Hospital of Zhejiang University
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

65 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 59 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, Acute

Criteria

7 inclusion criteria required to participate
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).

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5 exclusion criteria prevent from participating
Diagnosed or receiving treatment for other malignant tumors other than AML that are or are in need of treatment in the near future.

Acute promyelocytic leukemia, myeloid sarcomas, accelerated and acute transformation of chronic myeloid leukemia.

Patients with severe liver and kidney function, cardiopulmonary insufficiency.

Uncontrolled or severe infection.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intervention: CHA

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, ChinaOpen The First Affiliated Hospital, Zhejiang University School of Medicine in Google Maps
CompletedOne Study Center