Recruiting PHASE2 Acute Monocytic Leukemia

Compares treatment options for Acute Monocytic Leukemia

Official title Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia

ClinicalTrials.gov ID: NCT07512700

What this study is testing

What is CACAG+VEN?

CACAG+VEN is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for acute monocytic leukemia.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 14 to 60

You may be able to join if

  • Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures.
  • Age 14 to 60 years at screening, no gender restriction.
  • Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia.
  • No history of severe allergic reactions.
  • Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN.

You likely can't join if

  • Known hypersensitivity or contraindication to any study drug.
  • Pregnancy or lactation.
  • Active infection.
  • Long-term smoking or alcohol abuse that may interfere with study outcome evaluation.
  • Psychiatric illness or other condition that prevents informed consent or compliance with study procedures.
  • Major organ surgery within 6 weeks prior to enrollment.
See the full eligibility criteria
Who can join
  • Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures.
  • Age 14 to 60 years at screening, no gender restriction.
  • Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia.
  • No history of severe allergic reactions.
  • Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN.
  • Renal function: serum creatinine ≤ 1.5 × ULN
  • No uncontrolled infection or severe psychiatric disorder.
  • ECOG performance status 0-3; life expectancy ≥ 4 months.
What rules you out
  • Known hypersensitivity or contraindication to any study drug.
  • Pregnancy or lactation.
  • Active infection.
  • Long-term smoking or alcohol abuse that may interfere with study outcome evaluation.
  • Psychiatric illness or other condition that prevents informed consent or compliance with study procedures.
  • Major organ surgery within 6 weeks prior to enrollment.
  • Abnormal liver function: total bilirubin \> 2× ULN, ALT/AST \> 2.5 × ULN; abnormal renal function: serum creatinine \> 1.5 × ULN.
  • Any condition deemed unsuitable for the study by the investigator (e.g., poor compliance, substance abuse).

The study team makes the final eligibility decision.

Where it's taking place

  • Beijing, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 14 years to 60 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.