RecruitingPhase 2NCT03586609

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

145 participants

Start Date

Oct 25, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of four drugs — venetoclax, cladribine, low-dose cytarabine, and azacitidine — in older or less-fit adults who have been newly diagnosed with acute myeloid leukemia (AML), a type of blood cancer, and are not suitable for standard intensive chemotherapy. **You may be eligible if...** - You have been newly diagnosed with acute myeloid leukemia (AML) and have not yet received treatment for it (minor prior stabilizing treatments may be allowed) - You are 50 years of age or older, OR you are younger but cannot safely tolerate standard induction chemotherapy - Your liver, kidney, and organ function meet the required levels **You may NOT be eligible if...** - You have already received treatment for AML (beyond the minor exceptions listed) - You are under 50 and are a suitable candidate for standard induction chemotherapy - Your organ function is too impaired to safely receive the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine

Given SC or IV

DRUGCladribine

Given IV

DRUGCytarabine

Given SC

DRUGVenetoclax

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03586609


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