Combining venetoclax, cladribine, low dose cytarabine, and azacitidine for treating 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
This study is testing a new combination of medications for people with untreated acute myeloid leukemia to see if it helps them respond better to treatment and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 145 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03586609 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of a combination treatment involving venetoclax, cladribine, low dose cytarabine, and azacitidine in patients with previously untreated acute myeloid leukemia (AML). The study aims to assess the complete response rate, overall survival, disease-free survival, and overall response rate among participants. Additionally, it will investigate the toxicity and induction mortality associated with this treatment regimen. The trial also includes exploratory objectives to evaluate the pharmacokinetics of venetoclax and its correlation with treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 and older with previously untreated acute myeloid leukemia.
Not a fit: Patients with acute myeloid leukemia who have received prior treatment or are younger than 50 without suitable conditions for standard therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve response rates and survival outcomes for patients with acute myeloid leukemia.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating acute myeloid leukemia, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Tapan M Kadia — M.D. Anderson Cancer Center
- Study coordinator: Tapan Kadia
- Email: kadia@mdanderson.org
- Phone: 713-563-3534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.