RightFit
RecruitingPhase 2

Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Phase II Study of Venetoclax Added to Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed by Consolidation With Cladribine Plus LDAC Alternating With 5-Azacitidine With Venetoclax in Patients With Untreated AML

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 28 days, 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity."
  • "After completion of study treatment, patients are followed up every 6-12 months for 5 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase II study tests how well venetoclax, cladribine, low-dose cytarabine, and azacitidine treat acute myeloid leukemia (AML), a blood cancer. It is for people with AML that has not been treated, though some earlier treatments are allowed. Most participants must be age 50 or older, but some younger adults may qualify.

This phase II trial studies how well venetoclax, cladribine, low dose cytarabine, and azacitidine work in treating patients with acute myeloid leukemia that has previously not been treated. Drugs used in chemotherapy, such as venetoclax, cladribine, and low dose cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax, cladribine, low dose cytarabine induction followed by cladribine, low dose cytarabine, and azacitidine consolidation may work better in treating patients with acute myeloid leukemia.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have AML that has not been treated. Some earlier treatments are allowed: hydroxyurea, blood cell growth drugs, hypomethylating agents (HMA), all-trans retinoic acid (ATRA), or up to 2 grams of cytarabine for emergency care.
  • Be age 50 or older. People under 50 who cannot have standard starting treatment may qualify after discussion with the lead study doctor.
  • Have liver and kidney blood tests within study limits. Some liver test changes may be allowed if doctors find that leukemia caused them.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours (ECOG score of 0–2).
  • If you can become pregnant, have a negative urine pregnancy test within 1 week before joining.
  • Be able to understand the study requirements and sign a form agreeing to take part before joining.

Who can't join

  • Be pregnant. Breastfeeding must also be avoided because treatment may harm a nursing baby.
  • Have an uncontrolled illness, such as an infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat.
  • Have a mental health condition or life situation that would prevent following study requirements.
  • Have a known allergy to any part of the study treatment.
  • Be a man or a woman who can become pregnant and not agree to use birth control before joining and throughout the study.
  • Have taken venetoclax before.
  • Have acute promyelocytic leukemia (AML-M3), a type of AML.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Participants with previously untreated acute myeloid leukemia (AML). Prior therapy with hydroxyurea, hematopoietic growth factors, HMA, ATRA, or a total dose of cytarabine up to 2g (for emergency use for stabilization) is allowed. 2. Age \>/= 50 years. Participants aged \< 50 years who are unsuitable for standard induction therapy may be eligible after discussion with primary investigator 3. Adequate organ function as defined below: * liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN). Unless liver enzyme abnormalities are determined by the treating MD and PI to be due to leukemic infiltration. * kidney function (creatinine \< 1.5 x ULN ). 4. ECOG performance status of ≤ 2. 5. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 6. Participants must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the participants is required prior to their enrollment on the protocol. Exclusion Criteria: 1. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided. 2. Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 3. Participants with documented hypersensitivity to any of the components of the chemotherapy program. 4. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. 5. Prior therapy with venetoclax 6. Participants with a diagnosis of acute promyelocytic leukemia (AML-M3) will be excluded from this study.

Study sites (1)

TX