RecruitingPhase 1NCT05263284

8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia

A Phase 1 Trial of 8-Chloro-Adenosine in Combination With Venetoclax in Patients With Relapsed/Refractory Acute Myeloid Leukemia


Sponsor

City of Hope Medical Center

Enrollment

30 participants

Start Date

Dec 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of a new 8-chloroadenosine in combination with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). 8-Chloroadenosine may help block the formation of growths that may become cancer. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving 8-chloroadenosine in combination with venetoclax may help prevent the disease from coming back in patients with acute myeloid leukemia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — 8-chloroadenosine and venetoclax — for people with acute myeloid leukemia (AML, a type of blood cancer) that has returned after treatment or never fully responded to prior treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with AML that has relapsed or is refractory (did not respond to treatment) - You have failed at least one salvage therapy, or you have AML that did not fully respond after two lines of treatment - You are in reasonably good physical condition (ECOG 0–2) and expected to live more than 3 months **You may NOT be eligible if...** - You have AML that has spread to the brain - You have active uncontrolled infections (including HIV, hepatitis B or C) - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding - You are taking medications that strongly interact with 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

DRUG8-Chloroadenosine

Given IV

DRUGVenetoclax

Given PO


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT05263284


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