Actively Recruiting
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Led by Jennifer Saultz · Updated on 2026-03-24
51
Participants Needed
3
Research Sites
437 weeks
Total Duration
On this page
Sponsors
J
Jennifer Saultz
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Age 18 years or older
- Diagnosed with relapsed or refractory AML or secondary AML after at least one prior AML therapy
- Prior treatment with venetoclax and azacitidine allowed
- Hydroxyurea treatment not counted as prior therapy
- Patients with myelodysplastic syndrome that progressed on hypomethylating agent therapy and ineligible for intensive chemotherapy due to severe cardiac, pulmonary, kidney, liver disorders, ECOG status 2, or other comorbidities
- ECOG performance status 0 to 2
- Negative pregnancy test within 14 days before starting study drug for persons of childbearing potential
- Agree to use effective contraception during treatment and for specified periods after last dose
- Able to take and absorb oral medications
- Creatinine clearance 30 mL/min or higher
- Total serum bilirubin 1.5 times upper limit of normal or less unless due to leukemia
- AST and/or ALT 3 times upper limit of normal or less unless due to leukemia
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL or AML M3 subtype)
- Active central nervous system involvement with AML
- Chemotherapy or non-investigational therapy within 1 week before study start, except hydroxyurea
- Investigational non-biologic therapy within 14 days or 5 half-lives before study start
- Investigational biologic therapy within 30 days before study start
- Active second cancer with expected survival less than 1 year
- Significant graft versus host disease requiring treatment change within 28 days
- Rapidly progressive disease or organ dysfunction
- Documented cardiac insufficiency or symptomatic shortness of breath needing oxygen
- Significant coagulation disorders
- Recent serious cardiovascular events within 2 months
- Significant liver disease or chronic active hepatitis B or C
- Untreated HIV or active hepatitis C, or chronic hepatitis B
- Active infection not well controlled by treatment
- History of tuberculosis or high risk for TB
- Recent major surgery within 2 weeks
- Unwilling to receive blood transfusions
- Use of medications that strongly interact with study drugs and cannot be changed
- Uncontrolled high white blood cell count above 50,000/mm3
- Known allergy to ruxolitinib, venetoclax, or azacitidine
- Breastfeeding during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Suspended
2
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
3
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Suspended
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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