Study on Using Fludarabine, Cytarabine, Idarubicin, and Venetoclax for Treating Acute Myeloid Leukemia

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60

ClinicalTrials ID:NCT07228273

Provider View

This clinical trial is comparing two different treatment plans for patients with acute myeloid leukemia (AML). It aims to find out if adding the drug venetoclax to a combination of chemotherapy drugs can be more effective than the standard treatment in controlling AML.

Patient Parameters

Program Overview

This study is testing a new treatment approach for acute myeloid leukemia (AML) by comparing two different combinations of chemotherapy drugs. The goal is to see if adding venetoclax to fludarabine, cytarabine, and idarubicin can better control AML compared to the standard treatment of cytarabine and daunorubicin. The study involves two phases of treatment: induction therapy, which aims to bring the leukemia into remission, and consolidation therapy, which aims to eliminate any remaining cancer cells.

Description

The main goal of this study is to see how well the new treatment works by measuring the number of patients who achieve complete remission without any detectable cancer cells. The study will also look at overall response rates, safety, and survival rates without disease progression. Participants will be randomly assigned to one of two treatment groups.

In the first group, patients will receive fludarabine, cytarabine, idarubicin, and venetoclax. This treatment will be given in cycles, with each cycle lasting 28 days. If the leukemia is under control after the first cycle, patients will move on to consolidation therapy, which involves additional cycles of the same drugs.

In the second group, patients will receive the standard treatment of cytarabine and daunorubicin. Like the first group, if the leukemia is under control after the first cycle, patients will proceed to consolidation therapy with more cycles of cytarabine.

Throughout the study, patients will undergo various tests, including heart scans and bone marrow biopsies, to monitor their health and the effectiveness of the treatment. After completing the study treatment, patients will have follow-up visits to check their progress.

Eligibility Criteria

Inclusion Criteria

  • Be able to understand the study and provide written consent.
  • Be between 18 and 65 years old.
  • Have a new diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with a certain level of cancer cells in the bone marrow.
  • Have not received previous treatment for AML, except for certain medications to reduce cancer cell levels.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be willing to undergo a stem cell transplant if needed.
  • Be able to take medications by mouth or through a feeding tube.
  • Have adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for six months after treatment.
  • Men must agree to use effective contraception during the study and for three months after treatment.

Exclusion Criteria

  • Have a specific type of leukemia (acute promyelocytic leukemia) or certain genetic mutations.
  • Have another active cancer within the past five years, except for certain early-stage skin cancers.
  • Have active central nervous system involvement with leukemia.
  • Have had major surgery within 28 days before starting treatment.
  • Have had a stem cell transplant within 100 days before starting treatment.
  • Be currently receiving other investigational therapies or chemotherapy, except for certain medications to reduce cancer cell levels.
  • Have previously been treated with a BCL-2 inhibitor within 12 months before starting treatment.
  • Have a history of severe allergic reactions to any of the study drugs.
  • Have inadequate organ function, including severe heart problems or uncontrolled angina.
  • Have a high white blood cell count.
  • Have difficulty swallowing or absorbing oral medications.
  • Have active liver disease or hepatitis B or C infection, unless under control.
  • Have HIV infection that is not well-controlled.
  • Have an uncontrolled infection.
  • Have a psychiatric illness or social situation that would limit compliance with the study.
  • Be unwilling to stop breastfeeding during the study and for six weeks after the last dose of study drug.

Locations

FACILITYZIPCITYSTATE
OHSU Knight Cancer Institute97239PortlandOregon

Get This Program In Your Inbox

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