Clin2
NCT05431257Possibly a fitRecruiting

Azacitidine plus venetoclax for older or unfit AML

Acute Myeloid Leukemia

Treatments studied

Part of Blood & lymphatic, Cancer clinical trials.

This Phase 2 study tests whether the combination of azacitidine and venetoclax can help people with acute myeloid leukemia (AML) who can’t handle standard intensive chemotherapy, including some relapsed or refractory cases. It also involves extra optional-style lab testing on your leukemia (bio-banking and “-omics” profiling) to learn which drug sensitivities may matter.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
117 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have AML (not acute promyelocytic leukemia) that is either unfit for standard treatment, relapsed, or refractory after prior therapy.
  • You agree to extra research testing (bio-banking and detailed leukemia profiling) and lab drug-sensitivity testing.
  • Your health status is limited but not too high risk: ECOG is ≤2 if age 75+, or ≤3 if age 18–74.
  • Your blood counts fit the study: white blood cell count must be < 25 (you may use hydroxyurea to reach this).
  • Your kidneys and liver are strong enough: creatinine clearance ≥30 and liver blood tests meet limits (ALT and bilirubin).
  • You can’t have certain exclusions, including prior venetoclax for a myeloid cancer, AML with CNS involvement, or being at too high relapse level (4th relapse or more).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

Similar studies

Other trials that look related to this one.

NCT05904106Recruiting· Phase 2
Venetoclax plus azacitidine versus stronger chemotherapy for AML

This Phase 2 trial compares two treatment approaches for people newly diagnosed with a specific type of AML (bone marrow cancer) that has an NPM1 mutation: venetoclax plus azacitidine versus intensive (strong) chemotherapy. It aims to see which plan works better and is safer for “fit” patients.

Essen, North Rhine-Westphalia
NCT03586609Recruiting· Phase 2
New treatment for older adults with untreated AML

This Phase 2 trial tests a combination of venetoclax, cladribine, low-dose cytarabine, and azacitidine in people with untreated acute myeloid leukemia (AML). It may help shrink the leukemia and improve blood counts by trying a stronger, multi-drug approach.

Houston, Texas
NCT04905810Recruiting· Phase 2
Azacitidine or decitabine plus venetoclax for AML after prior failure

This trial studies whether adding venetoclax to either azacitidine or decitabine can treat acute myeloid leukemia (AML) when earlier “hypomethylating” treatment has stopped working. You might be a candidate if you’ve already tried azacitidine or decitabine for a related blood condition and it failed, and you meet the health-safety limits.

Clovis, California
NCT07044687Recruiting· Phase 4
Venetoclax with azacitidine for newly diagnosed AML

This trial tests a combination of oral venetoclax and injected azacitidine for adults who are newly diagnosed with acute myeloid leukemia (AML) and cannot have standard strong chemotherapy. The goal is to see how well this treatment works and what side effects it may cause.

Gurgaon, Haryana
NCT05834244Recruiting· Phase 1
New and relapsed AML treatment using azacitidine, venetoclax, and NK cells

This Phase 1 trial tests a combination of azacitidine, venetoclax, and donor NK cells to treat acute myeloid leukemia (AML) or certain AML-like syndromes. It’s designed mainly to find safe dosing and whether this approach can control the leukemia.

Cleveland, Ohio
NCT07407660Not yet recruiting· Phase 3
Shorter venetoclax for older or frail AML patients

This trial tests if a shorter course of venetoclax, based on early bone marrow results, works as well as the standard longer course. It is for older adults or younger patients with health issues that make standard intensive chemo too risky.

Hear when a new Acute Myeloid Leukemia trial opens

We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.