RecruitingPhase 1NCT03874052

Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase I Study to Evaluate Safety of Ruxolitinib in Combination With Azacitidine + Venetoclax in Patients With Relapsed/Refractory Acute Myeloid Leukemia


Sponsor

Jennifer Saultz

Enrollment

51 participants

Start Date

Aug 16, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects and best dose of ruxolitinib when given together with venetoclax and compares the effect of ruxolitinib in combination with venetoclax to venetoclax and azacitidine in treating patients with acute myeloid leukemia (AML) that has come back (relapsed) or has not responded to treatment (refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine stops cells from making deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. 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 ruxolitinib in combination with venetoclax and azacitidine may be safe, tolerable, and/or effective compare to ruxolitinib with venetoclax in treating patients with relapsed or refractory AML.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — ruxolitinib, venetoclax, and sometimes azacitidine — in people with acute myeloid leukemia (AML) or secondary AML that has come back or stopped responding to prior treatment. All three drugs target different survival pathways in leukemia cells, and the goal is to find a more effective combination. **You may be eligible if...** - You are 18 or older - You have been diagnosed with AML or secondary AML that has relapsed or stopped responding to treatment - You have received at least one prior therapy for AML - Prior treatment with venetoclax and azacitidine is permitted - Patients with MDS that progressed on treatment may also qualify **You may NOT be eligible if...** - You have certain active infections or serious heart conditions - You are pregnant or breastfeeding - You have had a recent stem cell transplant with active graft-versus-host disease - Your organ function is too low to safely tolerate 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 IV or SC

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREPunch Biopsy

Undergo skin punch biopsy

OTHERQuestionnaire Administration

Ancillary studies

DRUGRuxolitinib

Given PO

DRUGVenetoclax

Given PO


Locations(3)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT03874052


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