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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06050941
• Other study ID #: 20230413IAVEN
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2, 2024
• Est. completion date: April 2, 2027

Study information

• Verified date: April 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Weiyan Zheng, MD
• Phone: 86-13857187088
• Email: zhengwy2015[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2, 2027
• Est. primary completion date: April 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• idarubicin
Idarubicin 6mg/m2 d5-7
• Cytarabine
Cytarabine 60mg/m2 d5-9

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CR	assessment of the composite complete remission rate (CR=CR+CRi)	Week 6
Secondary	MRD	assessment of bone marrow measurable residual disease by flow cytometry	Week 6
Secondary	EFS	Evaluate the event-free survival	2 years
Secondary	OS	Evaluated the overall survival	2 years
Secondary	adverse events	Monitor of adverse events	at any time