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

NCT06050941 | Not Yet Recruiting Phase 2

• 1 other identifier: 20230413IAVEN
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• CR

  assessment of the composite complete remission rate (CR=CR+CRi)

  Week 6

Secondary Outcomes (4)

• MRD

  Week 6

• EFS

  2 years

• OS

  2 years

• adverse events

  at any time

Study Arms (1)

treatment group

EXPERIMENTAL

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

Drug: idarubicin; Drug: Cytarabine

Interventions

idarubicin DRUG

Idarubicin 6mg/m2 d5-7

Also known as: Idamycin, Demethoxydaunorubicin

treatment group

Cytarabine DRUG

Cytarabine 60mg/m2 d5-9

Also known as: Cytosar, Cytosine arabinoside

treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Idarubicin; Cytarabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Weiyan Zheng, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiyan Zheng, MD

CONTACT

86-13857187088; zhengwy2015@163.com

Xuepin Luo, MD

CONTACT

86-15167157190; luoxp1603@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: September 22, 2023
• Study Start: April 2, 2024
• Primary Completion: April 2, 2026
• Study Completion (Estimated): April 2, 2027
• Last Updated: March 5, 2024

Record last verified: 2023-04