Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults AML and MDS

Phase 2

Not yet recruiting

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes
• Interventions: Drug: idarubicin; Drug: Cytarabine

• Registration Number: NCT06050941
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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

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 Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-22
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-05
• Study Start: 2024-04-02
• Primary Completion: 2026-04-02
• Study Completion: 2027-04-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. aged 18-60 years
2. 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.
3. Eastern Cooperative Oncology Group performance status of 0-2.
4. adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography.

Exclusion Criteria

1. younger than 18 years old, or older than 60 years old.
2. Diagnosed as acute promyelocytic leukaemia.
3. Pretreated with anthracycline.
4. CNS involvement.
5. Positive for HIV, hepatitis B virus, or hepatitis C virus.
6. 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
7. Uncontrollable systemic infection (viral, bacterial, or fungal),
8. Inability to sign the informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	Cytarabine	Reduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy
treatment group	idarubicin	Reduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy

Primary Outcome Measures

Name	Time	Method
CR	Week 6	assessment of the composite complete remission rate (CR=CR+CRi)

Secondary Outcome Measures

Name	Time	Method
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