Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT05906914

Completed

CHA: Cladribine Plus Homoharringtonine and Cytarabine Regimen (CHA) for de Novo Acute Myeloid Leukemia

Interventional

Phase 2

The First Affiliated Hospital, Zhejiang University School of Medicine

Sponsor: First Affiliated Hospital of Zhejiang University

Last Updated: May 7, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

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Treatment Category

Chemotherapy, Other Drugs

Required Mutations

None

Trial Started

October 26, 2022

Last Updated by Sponsor

May 7, 2025

Estimated Completion

August 31, 2025

Contact Study

Name:Zhen Cai, MD, Ph.D

Email:caiz@zju.edu.cn

Phone:+86 138 5719 0311

Eligibility

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.

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll30

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Intervention: CHA

Interventions:

cladribine + homoharringtonine + cytarabine

Outcome Measures

Primary Outcome Measures

Complete response (CR) rateAt the end of Cycle 1 (each cycle is 28 days)

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

Overall Survival Rate2 years since enrollment

the ratio of cases alive to total enrolled cases within 2 years since enrollment

Disease-free Survival Rate2 years since enrollment

the ratio of cases with leukemia complete remission to the total enrolled cases within 2 years since enrollment

Secondary Outcome Measures

Recurrence Rate2 years since enrollment

the ratio of cases with leukemia relapse to the total enrolled cases within 2 years since enrollment

Treatment-related mortality30 days since treatment

the ratio of cases who died within 30 days since treatment to total enrolled cases

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Trial Sites

This study has 1 trial site

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, CN

Name:Jie Sun, MD, Ph.D

Recruiting

Hangzhou, Zhejiang, 310003 CN

The First Affiliated Hospital, Zhejiang University School of Medicine

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