Study on BCL2i CLAG-M for Treating Relapsed or Refractory Acute Myeloid Leukemia

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06660368

Provider View

This clinical trial is testing a new treatment combination for patients with acute myeloid leukemia (AML) that has returned or not responded to previous treatments. The study aims to see if adding the drug venetoclax to the existing CLAG-M therapy can improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with acute myeloid leukemia (AML) that has either come back after treatment or has not responded to initial therapies. The trial combines a treatment called CLAG-M with or without an additional drug, venetoclax, to see if it can better clear the disease and improve survival without events. Researchers believe that adding venetoclax to CLAG-M is safe and may work better than CLAG-M alone.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent and be willing to follow study procedures.
  • Adults aged 18 to 80 years.
  • Have relapsed or refractory AML, meaning the cancer has returned after treatment or has not responded to initial treatment.
  • Have secondary AML that developed from a previous condition called myelodysplastic syndrome (MDS) and was treated with certain therapies.
  • Have AML that affects the bone marrow and possibly other areas.
  • Be in good general health with an ECOG performance status of 0 to 2.
  • Have adequate organ function as specified in the study.
  • HIV-positive patients can participate if their viral load is undetectable with treatment.
  • Patients with hepatitis B or C can participate if their viral load is undetectable with treatment.
  • Women and men of childbearing potential must agree to use effective birth control during the study and for four months after.

Exclusion Criteria

  • Have AML that does not respond to venetoclax or have used venetoclax within three months before starting the study.
  • Have received certain high-dose chemotherapy treatments before.
  • Have had a stem cell transplant within the last three months.
  • Have received AML treatment within 14 days before starting the study, except for hydroxyurea.
  • Have a known TP53 mutation.
  • Have active AML in the central nervous system.
  • Have a white blood cell count of 25,000 or higher at the start of the study.
  • Have a serious illness that would prevent following the study.
  • Have another active cancer that requires treatment, with some exceptions.
  • Have used immunosuppressive therapy recently, except for low-dose prednisone.
  • Have not recovered from side effects of previous cancer treatments, except for hair loss.
  • Are taking other experimental drugs.
  • Have mental health or social issues that would prevent following the study.
  • Have heart disease that limits certain drug use or have had a recent heart attack.
  • Are pregnant or breastfeeding, as the study drugs may harm the baby.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.