Recruiting
Phase 2

Venetoclax, Cladribine, Low Dose Cytarabine, Azacitidine

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03586609

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Azacitidine

Cladribine

Cytarabine

Venetoclax

Study Details

Brief summary:

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.

Conditions

Acute Myeloid Leukemia

Study ID

NCT03586609

Start date

Oct 25, 2018

Status verified date

Jun, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

145 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (cladribine, cytarabine, venetoclax, azacitidine)

See Detailed Description.

Interventions

Azacitidine

Given SC or IV

Cladribine

Given IV

Cytarabine

Given SC

Venetoclax

Given PO

Primary outcome measure

  • Rate of complete response (CR/complete response with incomplete recovery [CRi]) [ Time Frame: Up to completion of cycle 2 (each cycle is 28 days) ]

Central Contacts and Locations

Central contacts

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Tapan M. Kadia

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-08.