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NCT05659992CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 8 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (actual)
First submitted
5 Dec 2022
Start date
25 Dec 2022
Primary completion date
14 Aug 2023
Lead sponsor
Chinese PLA General Hospital
NCT number
NCT05659992

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 30
  • From 25 Dec 2022 to the primary completion date, 14 Aug 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Less than 6 weeks after surgical operation of important organs.

Other illness

  • Patients with allergy or contraindication to the study drug;
  • 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;

Lab values

  • 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;

Other

  • Female patients who are pregnant or breast-feeding.
  • The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

Who the study is looking for

  • 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.

Age in the registry: 14 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese PLA General Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.