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A Study on the Efficacy and Safety of Venetoclax Combined With HAA Regimen in Newly Diagnosed Young AML.

Sponsor
ZePing Zhou (Other)
Overall Status
Recruiting
CT.gov ID
NCT05893472
Collaborator
Handan Central Hospital (Other), Taian City Central Hospital (Other), Tianjin People's Hospital (Other), Guizhou Provincial People's Hospital (Other), Second Xiangya Hospital of Central South University (Other), Western War Zone General Hospital (Other)
45
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the efficacy and safety of the combination of venetoclax and HAA regimen in young, newly diagnosed acute myeloid leukemia patients under the age of 60.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: combination of venetoclax and HAA regimen
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Second Affiliated Hospital of Kunming Medical University
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: The treatment group receiving the combination of venetoclax and HAA regimen.

Received induction therapy protocol： Docetaxel (HHT) 2.5mg/㎡/day, days 3-7 Aclarubicin (Acla) 20mg/day, days 3-7 Cytarabine (Ara-c) 100mg/㎡/day, days 3-7 (given as a 24-hour infusion) Venetoclax (VEN): 100mg on day 1, 200mg on day 2, and 400mg on days 3-8.

Combination Product: combination of venetoclax and HAA regimen
Using the combination of venetoclax and HAA regimen as induction therapy in young, newly diagnosed adult acute myeloid leukemia patients under the age of 60.

Outcome Measures

Primary Outcome Measures

  1. Overall response rate (ORR) [up to 12 months]

    which evaluates the efficacy of patient induction therapy, including complete remission (CR), complete remission with incomplete blood count recovery (CRi), and morphologic leukemia-free state (MLFS)

Secondary Outcome Measures

  1. Minimal residual disease (MRD) [up to 12 months]

    MRD percentage

  2. overall survival (OS) [up to 12 months]

    Overall Survival (OS) is used to evaluate all patients enrolled in a clinical trial, from the date of enrollment until death from any cause or the date of last follow-up for surviving patients.

  3. relapse-free survival (RFS) [up to 12 months]

    Relapse-Free Survival (RFS) is only used to evaluate patients who achieve complete remission (CR) through reinduction therapy. RFS is defined as the time from achievement of CR until death from any cause, relapse, or the date of last follow-up.

  4. 30-day mortality rate [Within 30 days after starting the medication]

    The 30-day mortality rate is used to evaluate all patients enrolled in a clinical trial, and is defined as the percentage of patients who die within 30 days of starting chemotherapy.

  5. adverse drug reactions [up to 12 months]

    Adverse drug reactions during chemotherapy and follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The eligible subjects for enrollment in this study must meet all of the following criteria:

  1. Patients with acute myeloid leukemia (excluding APL) who meet the diagnostic criteria of the World Health Organization (WHO) 2016 classification.

  2. Patients with AML and multilineage dysplasia (MDS) and/or myeloproliferative neoplasms (MPN) who meet the WHO criteria without prior history of MDS or MPN.

  3. Patients with AML who are not classified separately according to the WHO classification, except for those with acute megakaryoblastic leukemia with bone marrow fibrosis or myeloid sarcoma.

  4. Age greater than 16 years and less than 60 years, regardless of gender.

  5. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2.

  6. Requirements for laboratory parameters (within 7 days prior to treatment initiation) include: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3 times the upper limit of normal (ULN); serum bilirubin ≤2×ULN; serum cardiac enzyme <2.0×ULN; serum creatinine ≤2.0×ULN; and echocardiogram (ECHO)-determined ejection fraction within the normal range.

  7. A signed informed consent form is required before any study-specific procedures are performed. Patients 18 years and older may sign the informed consent form themselves or have it signed by their next of kin. Patients under 18 years of age must have the informed consent form signed by their legal guardian. In consideration of the patient's medical condition, if it is not in the patient's best interest to sign the form, the legal guardian or patient's next of kin may sign the form on the patient's behalf.

Exclusion Criteria:
  • Subjects meeting any of the following criteria will be excluded from this study:

  1. Previously treated patients (including those who have undergone induction chemotherapy regardless of treatment response).

  2. Secondary leukemia (including therapy-related AML subtype according to the World Health Organization (WHO) classification and those with a history of MDS and/or MPD).

  3. Concomitant hematologic diseases (such as hemophilia or myelofibrosis) deemed unsuitable for inclusion by the investigator; individuals with prior abnormal blood counts are allowed to participate if they have been previously excluded from MDS and MPD.

  4. Other malignant tumors requiring treatment.

  5. Pregnant or lactating women. Female participants of childbearing potential must have a negative pregnancy test within 7 days prior to the start of the trial. Male or female participants must take contraceptive measures during the trial and for 3 years after completion of treatment.

  6. Significant abnormalities in liver or kidney function beyond the inclusion criteria.

  7. Active heart disease, defined as one or more of the following:

  8. History of uncontrolled or symptomatic angina pectoris;

  9. Myocardial infarction within 6 months prior to enrollment;

  10. History of arrhythmia requiring medication or with severe clinical symptoms;

  11. Uncontrolled or symptomatic congestive heart failure (> NYHA class 2);

  12. Ejection fraction below the lower limit of the normal range. 8. Severe infectious diseases (e.g., unhealed tuberculosis or pulmonary aspergillosis).

  13. Participants deemed unsuitable for inclusion by the investigator.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital of Kunming Medical University. Kunming Yunnan China

Sponsors and Collaborators

  • ZePing Zhou
  • Handan Central Hospital
  • Taian City Central Hospital
  • Tianjin People's Hospital
  • Guizhou Provincial People's Hospital
  • Second Xiangya Hospital of Central South University
  • Western War Zone General Hospital

Investigators

  • Study Chair: DanQi Deng, The Second Affiliated Hospital, Kunming Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ZePing Zhou, Dr., The Second Affiliated Hospital of Kunming Medical University
ClinicalTrials.gov Identifier:
NCT05893472
Other Study ID Numbers:
  • SHEN-PJ-KE-2023-125
First Posted:
Jun 8, 2023
Last Update Posted:
Jun 8, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Venetoclax

Study Results

No Results Posted as of Jun 8, 2023