Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult

February 27, 2024 updated by: ZePing Zhou, The Second Affiliated Hospital of Kunming Medical University

The Second Affiliated Hospital of Kunming Medical University

This study proposes to conduct a prospective, multicenter, single-arm study to explore the efficacy and safety of venetoclax in combination with high-dose decitabine (DEC3-VEN) in new diagnosed adult patients with AML, and to provide evidence for the optimal selection of clinical treatment regimens, which is planned to be conducted in 10 research centers across the country.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

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

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China
        • The Second Affiliated Hospital of Kunming Medical University.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects suitable for enrollment in this study must meet all of the following criteria:

  1. meet the World Health Organization diagnostic criteria (WHO2022 criteria) other than APL or carrying one of the abnormal karyotypes such as t(8;21)/(RUNX1::RUNX1TI), inv(16)(p13.1q22), t(16;16) (p13.1q22), t(16;16)/CBFβ::myh11), etc. Patients with acute myeloid leukemia other than those with one of the abnormal karyotypes such as t(16;16)/CBFβ::myh11
  2. Patients with AML not otherwise classified under the World Health Organization AML classification, except for acute myeloproliferative disorder with myelofibrosis and myeloid sarcoma;
  3. patients of either sex, age greater than or equal to 16 years and less than 65 years, with a primary diagnosis of AML, who are considered suitable for intensive chemotherapy;
  4. Eastern Cooperative Oncology Group (ECOG) physical status ≤ 2 at enrollment;
  5. the patient has not received prior treatment for AML (except hydroxyurea and Ara-C <1.0 g/d for tumor composite reduction);
  6. passes the following laboratory test markers (performed within 7 days prior to treatment):1) aspartate aminotransferase (ALT), alanine aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN), serum bilirubin ≤ 2 x ULN; and serum cardiac enzymes < 2.0 x ULN; unless leukemic organ involvement is considered.2) Creatinine ≥ 30 mL/min, calculated by the Cockcroft Gault formula or measured by 24-hour urine collection
  7. Female subjects of childbearing potential must have a negative pregnancy test result within 72 hours prior to the start of treatment; no pregnancy is planned during the study and within 6 months of the last dose of study drug, and a negative urine or serum pregnancy test result at screening. Men must use latex condoms during any sexual contact with WOCBP, even if they have undergone a successful vasectomy, and must agree to avoid childbearing (during treatment and within 6 months of the last dose of study drug);
  8. have a life expectancy of more than 2 months;
  9. informed consent must be signed prior to the start of all specific study procedures, either by the patient himself/herself or by a member of his/her immediate family; if, in view of the patient's medical condition, his/her own signature would not be conducive to the treatment of his/her medical condition, the informed consent will be signed by his/her legal guardian or by a member of the patient's immediate family.

Exclusion Criteria:

Subjects may not be enrolled in this study if they meet any of the following criteria:

  1. AML with BCR-ABL1; or CML acute stage;
  2. Treatment-naïve patients (is defined as having received prior induction chemotherapy regardless of efficacy);
  3. Subjects with acute total myelopathy with myelofibrosis or myeloid sarcoma as defined by WHO 2016;
  4. Secondary leukemia (primarily those whose World Health Organization (WHO 2016) AML classification falls into the subcategory of treatment-related AML and those with a history of prior MDS and/or MPD);
  5. concurrent other hematologic diseases (e.g., hemophilia, myelofibrosis, etc., who are considered unsuitable for enrollment by the investigator; those who have previous blood abnormalities but have ever had bone marrow tests except for MDS and MPD are allowed to be enrolled);
  6. Pregnant or lactating patients;
  7. Those who are allergic to any drugs involved in this study;
  8. Have used strong or moderate CYP7A inducers within 3 days prior to the start of study treatment;
  9. concurrent malignant tumors of other organs (those requiring treatment);
  10. Significantly abnormal hepatic or renal function beyond the enrollment criteria;
  11. Active heart disease, defined as one or more of the following:1) Myocardial infarction less than 6 months from study entry; 2) A history of arrhythmia requiring medication or severe clinical symptoms; 3) Uncontrolled or symptomatic congestive heart failure (> NYHA class 2); 4) Uncontrolled or symptomatic angina;5) Left ventricular ejection fraction below the lower limit of the normal range;
  12. severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis), patients with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C; subjects with uncontrolled treatment.
  13. Subjects with evidence of central nervous system leukemia prior to treatment;
  14. Subjects with epilepsy requiring medication, dementia, or other abnormal mental states that are unable to understand or follow the regimen;
  15. Conditions that limit oral drug intake or gastrointestinal absorption;
  16. those who, in the opinion of the investigator, are not suitable for enrollment;

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 in combination with Decitabine (+-sorafenib)
Venetoclax in combination with decitabine (+-sorafenib) Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-14 Decitabine (DEC) 20mg/m2/q8h, d4-6 (infusion time >2h) Sorafenib 800mg/d, d8-14 (only for FLT3/ITD mutation positive patients)
Procedure: DEC3-VEN
Venetoclax in combination with decitabine (+-sorafenib) Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-14 Decitabine (DEC) 20mg/m2/q8h, d4-6 (infusion time >2h) Sorafenib 800mg/d, d8-14 (only for FLT3/ITD mutation positive patients)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 24 months
ORR (include CR, CRi, MLFS, PR) of the first course of Venetoclax in combination with high-dose decitabine for the treatment of newly-diagnosed AML adult patients.
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 24 months
defined as the time period from initiation of study medication to death from any cause.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Kunming Medical University

Collaborators

Guizhou Provincial People's Hospital
Central South University
First Affiliated Hospital of Guangxi Medical University
Tianjin People's Hospital
Taian City Central Hospital
Handan Central Hospital
Institute of hematology hospital,Chinese Academy of Medical Sciences
Western Theater General Hospital
Chengdu Jingdongfang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Estimated)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SHEN-PJ-KE-2024-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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