Acute Myeloid Leukemia, AdultPhase 2CHANCT05906914
Cladribine Plus Homoharringtonine and Cytarabine Regimen (CHA) for de Novo Acute Myeloid Leukemia
A Phase 2 study testing cladribine + homoharringtonine + cytarabine in people with Acute Myeloid Leukemia, Adult, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Acute Myeloid Leukemia, Adult
- What is being tested?
- cladribine + homoharringtonine + cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2022to 31 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
About this study
Official title: 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)
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.
Read the detailed description
In this study, a new chemotherapy regimen named CHA which composed of cladribine, homoharringtonine and cytarabine, was proposed for the induced remission treatment of adult acute myeloid leukemia, and the efficacy and safety of this regimen were evaluated. Enrolled patients will receive cladribine (5mg/m2, d1-3) + homoharringtonine (2mg/m2, d1-5) + cytarabine (100mg/m2, d1-7). If more than partial remission is achieved in the first course, a course of CHA regimen is repeated. If the first course of treatment did not achieve a partial response, or the second course of treatment did not achieve a complete response, the patient was withdrawn from the clinical study. Transplantation was stratification according to the prognostic risk stratification. Patients with favourable risk received 3 cycles of high-dose intravenous cytarabine (1-3g/m2, Q12H d1-3). Or 3 cycles of medium dose cytarabine (1.0g/m2, Q12H d1-3) combined with idarubicin (10mg/m2, d1-3) or etoposide (100mg, d1-3). Patients with intermediate risk who achieve minimal residual disease (MRD) negative in the first or second cycle can receive high-dose or intermediate-dose cytarabine chemotherapy, otherwise allogeneic hematopoietic stem cell transplantation (HSCT) is recommended. Patients with high risk are advised to receive allogeneic HSCT, or receive high-dose or intermediate-dose cytarabine.Bone marrow samples were collected at enrollment for bone marrow cytology, flow cytometry and next-generation sequencing. The probes for targeted sequencing covered exons and selected introns of 88 myeloid leukaemia-related genes for next-generation sequencing. Bone marrow was collected on day 28 after each treatment cycle, including bone marrow cytology and measurable residual disease (MRD) assessments, for response assessment.The response assessment was evaluated 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. The primary study endpoint was the composite complete remission (CR) rate (CR and CR with incomplete hematology recovery, CRi), assessed in all treated populations 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. The secondary endpoints were minimal residual disease in bone marrow measured by flow cytometry after one cycle of induction therapy, as well as overall survival (OS), event-free survival, and adverse events, assessed in all treated populations.
- Conditions
- Acute Myeloid Leukemia, Adult
- Being tested
- cladribine + homoharringtonine + cytarabine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cladribine + homoharringtonine + cytarabineDrug
Also called Cladribine Injection, Cytarabine for injection, Homoharringtonine Injection
CHA Protocol: cladribine (5mg/m2, d1-3) + homoharringtonine (2mg/m2, d1-5) + cytarabine (100mg/m2 d1-7).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Intervention: CHA Receives: Drug: cladribine + homoharringtonine + cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 2 years since enrollment
Secondary outcomes (2)
Recurrence Rate
the ratio of cases with leukemia relapse to the total enrolled cases within 2 years since enrollment
Measured: 2 years since enrollment
Treatment-related mortality
the ratio of cases who died within 30 days since treatment to total enrolled cases
Measured: 30 days since treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start26 Oct 2022
- Primary completion11 Apr 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, AdultStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Sun, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906914
- Sponsor's protocol ID
- IIT20220027C-R2
- Acronym
- CHA
- Status last verified
- Apr 2025
- First submitted
- 14 May 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05906914
- Acronym / sponsor ID
- CHA / IIT20220027C-R2
- Conditions
- Acute Myeloid Leukemia, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, a new chemotherapy regimen named CHA which composed of cladribine, homoharringtonine and cytarabine, was proposed for the induced remission treatment of adult acute myeloid leukemia, and the efficacy and safety of this regimen were evaluated. Enrolled patients will receive cladribine (5mg/m2, d1-3) + homoharringtonine (2mg/m2, d1-5) + cytarabine (100mg/m2, d1-7). If more than partial remission is achieved in the first course, a course of CHA regimen is repeated. If the first course of treatment did not achieve a partial response, or the second course of treatment did not achieve a complete response, the patient was withdrawn from the clinical study. Transplantation was stratification according to the prognostic risk stratification. Patients with favourable risk received 3 cycles of high-dose intravenous cytarabine (1-3g/m2, Q12H d1-3). Or 3 cycles of medium dose cytarabine (1.0g/m2, Q12H d1-3) combined with idarubicin (10mg/m2, d1-3) or etoposide (100mg, d1-3). Patients with intermediate risk who achieve minimal residual disease (MRD) negative in the first or second cycle can receive high-dose or intermediate-dose cytarabine chemotherapy, otherwise allogeneic hematopoietic stem cell transplantation (HSCT) is recommended. Patients with high risk are advised to receive allogeneic HSCT, or receive high-dose or intermediate-dose cytarabine.Bone marrow samples were collected at enrollment for bone marrow cytology, flow cytometry and next-generation sequencing. The probes for targeted sequencing covered exons and selected introns of 88 myeloid leukaemia-related genes for next-generation sequencing. Bone marrow was collected on day 28 after each treatment cycle, including bone marrow cytology and measurable residual disease (MRD) assessments, for response assessment.The response assessment was evaluated 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. The primary study endpoint was the composite complete remission (CR) rate (CR and CR with incomplete hematology recovery, CRi), assessed in all treated populations 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. The secondary endpoints were minimal residual disease in bone marrow measured by flow cytometry after one cycle of induction therapy, as well as overall survival (OS), event-free survival, and adverse events, assessed in all treated populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: cladribine + homoharringtonine + cytarabineIntervention: CHA |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cladribine + homoharringtonine + cytarabineAlso: Cladribine Injection, Cytarabine for injection, Homoharringtonine InjectionCHA Protocol: cladribine (5mg/m2, d1-3) + homoharringtonine (2mg/m2, d1-5) + cytarabine (100mg/m2 d1-7). | Drug | Experimental Group |
Primary outcome
Complete response (CR) rate
Time frame: At 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 Rate
Time frame: 2 years since enrollment
the ratio of cases alive to total enrolled cases within 2 years since enrollment
Disease-free Survival Rate
Time frame: 2 years since enrollment
the ratio of cases with leukemia complete remission to the total enrolled cases within 2 years since enrollment
2 secondary outcomes
Recurrence Rate
Time frame: 2 years since enrollment
Treatment-related mortality
Time frame: 30 days since treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Sun principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cladribine + homoharringtonine + cytarabine in people with Acute Myeloid Leukemia, Adult, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rate (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.