Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML

NCT05805098 | Recruiting Phase 2

• 1 other identifier: SZQ001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Defined as complete response (CR) + CR with incomplete blood count recovery (CRi) + morphologic leukemia-free state (MLFS) + partial response (PR).

  28 days after study treatment

Secondary Outcomes (3)

• Rate of Participants With Adverse Events

  Through 28 days post study medication administration

• Event-free survival

  Through study completion, up to 3 years

• Overall survival

  Through study completion, up to 3 years

Study Arms (1)

Venetoclax Combined With Homoharringtonine and Cytarabine

EXPERIMENTAL

All recipients in this arm received Venetoclax, Homoharringtonine and Cytarabine. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-28. Homoharringtonine was uesd as 1 mg/m2 qd from day-1 to day-5. Cytarabine was uesd as 100 mg/m2 qd from day-1 to day-5.

Drug: Venetoclax; Drug: Homoharringtonine; Drug: Cytarabine

Interventions

Venetoclax DRUG

Starting on day 1, venetoclax will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2 and 400 mg on day 3. The patient then continues to take the 400mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day.

Also known as: VEN

Venetoclax Combined With Homoharringtonine and Cytarabine

Homoharringtonine DRUG

On day 1, homoharringtonine 1 mg/m2 IV will be given, and will continue for 5 days.

Also known as: HHT

Venetoclax Combined With Homoharringtonine and Cytarabine

Cytarabine DRUG

On day 1, cytarabine 100 mg/m2 IV will be given, and will continue for 5 days.

Venetoclax Combined With Homoharringtonine and Cytarabine

Eligibility Criteria

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

You may qualify if:

• Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
• patients must have confirmation of AML by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance \< 45 mL/min. Moderate hepatic impairment with total bilirubin \> 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
• Patients \> 18 to ≤ 60 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2
• Laboratory values meeting the following criteria:Creatinine clearance ≥ 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection, Serum aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN) 、Serum alanine aminotransferase (ALT) ≤ 3.0 × ULN (Unless considered due to leukemic organ involvement), Total bilirubin ≤ 1.5 × ULN, White blood cell (WBC) count \< 25 × 109 /L (hydroxyurea is permitted to meet this criterion)

You may not qualify if:

• \> 60 years of age or \<18 years of age
• Acute promyelocytic leukemia (M3)
• Patient is ineligible for treatment with intensive chemotherapy
• Patient with active infection not controlled, active bleeding from vital organs
• Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study
• Patient has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.
• Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen.
• Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C
• Patients deemed unsuitable for enrolment by the investigator.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

Qiu Huiying

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Homoharringtonine; Cytarabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Harringtonines; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Huiying Qiu, PhD

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Huiying Qiu, PhD

CONTACT

13912792913; qiuhuiying@aliyun.com

Depei Wu, PhD

CONTACT

67781856; drwudepei@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: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 7, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 7, 2023

Record last verified: 2023-03

Locations

CN (1)