- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05805098
Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML (VHA)
March 28, 2023 updated by: The First Affiliated Hospital of Soochow University
Venetoclax in Combination With Homoharringtonine and Cytarabine in Newly Diagnosed Subjects With Acute Myeloid Leukemia: a Phase 2/3, the Single-arm, Open-label, Monocentric Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a phase II/III study that seeks to treat patients ages 18-60 who have acute myeloid leukemia but have never been treated before.
In order to improve the outcome of patients with primary AML, venetoclax combined with homoharringtonine and cytarabine was applied in the treatment of primary AML.
This study aims to evaluate the efficacy and safety of venetoclax in combination with homoharringtonine and cytarabine in newly diagnosed subjects with AML.Depending on the level of recovery, patients will either be forced to come off study or have the option to continue the medication, receive maintenance therapy, or pursue an allogeneic stem cell transplant.
After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huiying Qiu, PhD
- Phone Number: 13912792913
- Email: qiuhuiying@aliyun.com
Study Locations
-
-
Jiangsu
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Suzhou, Jiangsu, China, 215006
- Recruiting
- Qiu Huiying
-
Contact:
- Huiying Qiu, PhD
- Phone Number: 13912792913
- Email: qiuhuiying@aliyun.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- > 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Venetoclax Combined With Homoharringtonine and Cytarabine
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.
|
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.
Other Names:
On day 1, homoharringtonine 1 mg/m2 IV will be given, and will continue for 5 days.
Other Names:
On day 1, cytarabine 100 mg/m2 IV will be given, and will continue for 5 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: 28 days after study treatment
|
Defined as complete response (CR) + CR with incomplete blood count recovery (CRi) + morphologic leukemia-free state (MLFS) + partial response (PR).
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28 days after study treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Participants With Adverse Events
Time Frame: Through 28 days post study medication administration
|
Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post study medication administration.
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Through 28 days post study medication administration
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Event-free survival
Time Frame: Through study completion, up to 3 years
|
Defined as the number of days from the date of treatment initiation (i.e., course 1 day 1) to the date of documented treatment failure, relapses from CR, or death from any cause, whichever occurs first.
Will be calculated for all patients.
Estimated using Kaplan-Meier method.
Log-rank tests will be used to compare among subgroups of patients.
|
Through study completion, up to 3 years
|
Overall survival
Time Frame: Through study completion, up to 3 years
|
Estimated using Kaplan-Meier method.
Log-rank tests will be used to compare among subgroups of patients.
|
Through study completion, up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Huiying Qiu, PhD, The First Affiliated Hospital Of Soochow University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Anticipated)
March 1, 2025
Study Completion (Anticipated)
March 1, 2028
Study Registration Dates
First Submitted
March 28, 2023
First Submitted That Met QC Criteria
March 28, 2023
First Posted (Actual)
April 7, 2023
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Phytogenic
- Protein Synthesis Inhibitors
- Venetoclax
- Cytarabine
- Homoharringtonine
Other Study ID Numbers
- SZQ001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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