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NCT Number: NCT05659992

Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.

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Key information

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor. In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are able to understand and willing to sign the informed consent form (ICF).
  • All patients should aged 14 to75 years,no gender limitation.
  • Patients who are newly diagnosed with AML.
  • Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
  • Renal function: creatinine ≤the upper limit of normal;
  • Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
  • The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.
  • Patients without severe allergic constitution.

Exclusion criteria

  • Patients with allergy or contraindication to the study drug;
  • Female patients who are pregnant or breast-feeding.
  • Patients with active infection
  • Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
  • Patients with mental illness or other states unable to comply with the protocol;
  • Less than 6 weeks after surgical operation of important organs.
  • Liver function: ALT and AST>2.5 times the upper limit of normal ,bilirubin>2 times the upper limit of normal;Renal function: creatinine >the upper limit of normal;
  • The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

Treatment and study plan

azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte

Drug
  • azacytidine (75 mg/m2/day, days 1 to 7).
  • cytarabine (75 mg/m2 bid, days 1 to 5).
  • aclamycin (10 mg/m2/day, day1,3,5).
  • Chidamide (30 mg/day , days 0,3).
  • venetoclax (100 mg day 1, 200 mg day 2, 400mg days 3 to 14 ).
  • granulocyte colony-stimulating factor (5ug/kg/day, day 0 until agranulocytosis recovery)

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 1 month after study treatment

    Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).

Secondary outcomes

  1. Rate of Minimal Residual Disease (MRD)-Negative Response:

    Time frame: after two courses of chemotherapy (each course is 28 days)

    Percentage of participants who achieved MRD-negative response, defined as < 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry or < 0.01% as assessed by PCR of a bone marrow aspirate.

  2. Progression Free Survival (PFS)

    Time frame: 180 days after study treatment

    PFS was defined as time from the date joining the clinical study to the date of disease progression (PD) or date of death due to any cause, whichever occurred first.

  3. Overall Survival (OS)

    Time frame: 180 days after study treatment

    Defined as the time from joining the clinical study to death due to any cause.

  4. Rate of Participants With Adverse Events

    Time frame: Through 28 days post last study medication administration

    Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post last study medication administration.

  5. Partial Remission (PR) Rate:

    Time frame: 1 month after study treatment

    All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pre-treatment bone marrow blast percentage by at least 50 percent.

  6. Complete Remission (CR) Rate

    Time frame: 1 month after study treatment

    Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts &amp;lt;5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count &amp;gt;1.0 x 109/L (1000/µL); platelet count &amp;gt;100 x 109/L (100,000/µL); independence of red cell transfusions.

  7. CR with Incomplete Blood Count Recovery Rate

    Time frame: 1 month after study treatment

    All CR criteria except for residual neutropenia (&amp;lt;1.0 x 109/L (1000/µL)) or thrombocytopenia (&amp;lt;100 x 109/L (100,000/µL)

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Single Arm,open Label,phase I Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 21, 2022
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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