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

NCT05906914 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: IIT20220027C-R2
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Myeloid Leukemia, Adult

Outcome Measures

Primary Outcomes (3)

• Complete response (CR) rate

  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

  At the end of Cycle 1 (each cycle is 28 days)

• Overall Survival Rate

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

  2 years since enrollment

• Disease-free Survival Rate

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

  2 years since enrollment

Secondary Outcomes (2)

• Recurrence Rate

  2 years since enrollment

• Treatment-related mortality

  30 days since treatment

Study Arms (1)

Experimental Group

EXPERIMENTAL

Intervention: CHA

Drug: cladribine + homoharringtonine + cytarabine

Interventions

cladribine + homoharringtonine + cytarabine DRUG

CHA Protocol: cladribine (5mg/m2, d1-3) + homoharringtonine (2mg/m2, d1-5) + cytarabine (100mg/m2 d1-7).

Also known as: Cladribine Injection, Cytarabine for injection, Homoharringtonine Injection

Experimental Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Mental illness that may prevent subjects from completing treatment or informed consent.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cladribine; Homoharringtonine; Cytarabine; Injections

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Harringtonines; Alkaloids; Benzazepines; Heterocyclic Compounds, 4 or More Rings; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jie Sun

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: June 18, 2023
• Study Start: October 26, 2022
• Primary Completion: April 11, 2025
• Study Completion: October 31, 2025
• Last Updated: February 4, 2026

Record last verified: 2025-04

Locations

CN (1)