Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and Myelodysplastic Syndrome

Sponsor

First Affiliated Hospital of Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06050941

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Reduced intensive 3 + 5 idarubicin and cytarabine chemotherapy plus venetoclax as first-line treatment for adults with acute myeloid leukaemia and high-risk myelodysplastic syndrome

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes	Drug: idarubicin Drug: Cytarabine	Phase 2

Detailed Description

Multiple clinical trials about chemotherapy plus venetoclax in primary diagnosed AML or relapsed/refractly AML were ongoing to attempt the facility of the combination. Zu et al demostrated that full dose of 3 + 7 daunorubicin and cytarabine chemotherapy plus 8 days escalated venetoclax acheived 91% of CR/CRi with 97% 1-year overall survival and 72% 1-year event-free survival. In this trial , we try to reduced the intensive of 3 + 5 idarubicin and cytarabine chemotherapy, but prolong venetoclax to two weeks in the induction therapy in adults AML/MDS. We expect to increase the induced remission rate by extending the dosage of targeted drug venetoclax, and minimize the side effects by reducing the dose of 3 + 7 induction chemotherapy, so as to achieve the goal of high efficiency and low toxicity.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-center Prospective Single Arm Clinical Study of Reduced Intensive 3 + 5 Idarubicin and Cytarabine Chemotherapy Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndrome

Anticipated Study Start Date :

Oct 20, 2023

Anticipated Primary Completion Date :

Oct 20, 2025

Anticipated Study Completion Date :

Oct 20, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group Reduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy	Drug: idarubicin Idarubicin 6mg/m2 d5-7 Other Names: Idamycin Demethoxydaunorubicin Drug: Cytarabine Cytarabine 60mg/m2 d5-9 Other Names: Cytosar Cytosine arabinoside

Arm

Intervention/Treatment

Experimental: treatment group

Reduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy

Drug: idarubicin

Idarubicin 6mg/m2 d5-7

Other Names:

Idamycin

Demethoxydaunorubicin

Drug: Cytarabine

Cytarabine 60mg/m2 d5-9

Other Names:

Cytosar

Cytosine arabinoside

Outcome Measures

Primary Outcome Measures

CR [Week 6]
assessment of the composite complete remission rate (CR=CR+CRi)

Secondary Outcome Measures

MRD [Week 6]
assessment of bone marrow measurable residual disease by flow cytometry
EFS [2 years]
Evaluate the event-free survival
OS [2 years]
Evaluated the overall survival
adverse events [at any time]
Monitor of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

aged 18-60 years
had a confirmed diagnosis of previously untreated de novo acute myeloid leukaemia or high risk myelodysplastic syndrome by bone marrow examination according to the criteria presented by WHO.
Eastern Cooperative Oncology Group performance status of 0-2.
adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography.

Exclusion Criteria:

younger than 18 years old, or older than 60 years old.
Diagnosed as acute promyelocytic leukaemia.
Pretreated with anthracycline.
CNS involvement.
Positive for HIV, hepatitis B virus, or hepatitis C virus.
New York Heart Association cardiovascular disability status higher than grade 2 (grade 2 is defined as cardiac disorder that is asymptomatic at rest, but ordinary physical activity might result in fatigue, palpitations, dyspnoea, or angina), chronic respiratory diseases requiring continuous supplementary oxygen, inability to take oral medication or malabsorption syndrome
Uncontrollable systemic infection (viral, bacterial, or fungal),
Inability to sign the informed consent form.