← Back to Search

Kinase Inhibitor

Ruxolitinib + Venetoclax for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Jennifer Saultz, MD
Research Sponsored by Brian Druker
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first pr or better to loss of best response, or date of last assessment (up to 24 months)
Awards & highlights

Study Summary

This trial is testing the combination of two drugs to treat acute myeloid leukemia that has returned or not responded to treatment. The first drug, ruxolitinib, may stop cancer cell growth by blocking enzymes needed for cell growth. The second drug, venetoclax, is a BCL-2 inhibitor that may stop cancer cell growth by blocking a protein needed for cancer cell survival. This study is being done to see if the combination of these two drugs works better than standard of care chemotherapy.

Who is the study for?
Adults with relapsed or refractory acute myeloid leukemia (AML) who've had at least one prior treatment can join this trial. They must be able to take oral meds, have a certain level of organ function, and not be pregnant or breastfeeding. Contraception is required for participants of childbearing potential.Check my eligibility
What is being tested?
The trial tests the combination of ruxolitinib and venetoclax in AML patients whose disease has returned or resisted treatment. It aims to find the safest doses and see if these drugs are more effective than standard chemotherapy.See study design
What are the potential side effects?
Possible side effects include issues with blood cell counts leading to increased infection risk, bleeding problems, liver abnormalities, fatigue, nausea, diarrhea, and potential allergic reactions to the medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first pr or better to loss of best response, or date of last assessment (up to 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first pr or better to loss of best response, or date of last assessment (up to 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicities (DLT) of ruxolitinib and venetoclax in combination
Secondary outcome measures
Clinical benefit rate (CBR)
Composite complete remission rate
Duration of response
+3 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036
23%
Pruritus
12%
Headache
9%
Diarrhoea
9%
Upper respiratory tract infection
8%
Fatigue
8%
Asthenia
8%
Thrombocytopenia
7%
Nausea
7%
Dizziness
7%
Night sweats
7%
Haematocrit increased
5%
Influenza
5%
Weight decreased
5%
Erythema
5%
Decreased appetite
5%
Leukocytosis
5%
Constipation
4%
Thrombocytosis
4%
Abdominal pain upper
4%
Arthralgia
4%
Hypertension
3%
Pain in extremity
3%
Oedema peripheral
3%
Dyspnoea
3%
Epistaxis
3%
Bronchitis
3%
Abdominal discomfort
3%
Tinnitus
3%
Nasopharyngitis
3%
Myalgia
3%
Dyspepsia
3%
Cough
1%
Anaemia
1%
Vertigo
1%
Depression
1%
Weight increased
1%
Haematoma
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Syncope
1%
Respiratory failure
1%
Abdominal pain
1%
Neutropenia
1%
Muscle spasms
1%
Rectal haemorrhage
1%
Cellulitis
1%
Meningitis
1%
Pneumonia
1%
Septic shock
1%
Hyponatraemia
1%
Acute myeloid leukaemia
1%
Bladder transitional cell carcinoma
1%
Breast cancer
1%
Myelofibrosis
1%
Extremity necrosis
1%
Abdominal distension
1%
Flatulence
1%
Vomiting
1%
Pyrexia
1%
Blood lactate dehydrogenase increased
1%
Gamma-glutamyltransferase increased
1%
Hyperuricaemia
1%
Musculoskeletal pain
1%
Osteoarthritis
1%
Cardiac failure
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Best Available Therapy
All Crossover Patients
Ruxolitinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ruxolitinib, venetoclax)Experimental Treatment2 Interventions
Patients receive ruxolitinib PO BID and venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of ruxolitinib and venetoclax at the discretion of the sponsor-investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Ruxolitinib
2018
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

Brian DrukerLead Sponsor
AbbVieIndustry Sponsor
946 Previous Clinical Trials
496,441 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
361 Previous Clinical Trials
55,019 Total Patients Enrolled

Media Library

Ruxolitinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03874052 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Treatment (ruxolitinib, venetoclax)
Acute Myelogenous Leukemia Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT03874052 — Phase 1
Ruxolitinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03874052 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary illnesses that Ruxolitinib has been utilized to address?

"Ruxolitinib is typically used as an intervention for steroid refractory. It can also be employed to manage a variety of other conditions, including graft-vs-host disease, chronic lymphocytic leukemia (CLL), and non-immunocompromised disorders."

Answered by AI

What are the potential risks associated with taking Ruxolitinib?

"Our researchers at Power rated Ruxolitinib's safety a 1, as this is only Phase 1 and there is limited evidence of its efficacy and potential risks."

Answered by AI

How many participants have enrolled in this study?

"At present, this research is not receiving new patients. The trial first appeared in records on August 16th 2019 and was edited as recently as 8/10/2022. There are plenty of other clinical trials that may be suitable for you; specifically, there are 1,604 studies recruiting people with leukemia or myeloid conditions and 314 which recruit those being treated with Ruxolitinib."

Answered by AI

Are there any available slots to participate in this clinical research?

"Per the information on clinicaltrials.gov, this research endeavour is no longer recruiting participants and has not done so since August 10th 2022 when it was last updated. However, 1918 other trials are actively looking for patients at present time."

Answered by AI

To what extent has Ruxolitinib been investigated in the past?

"Currently, there are 314 Ruxolitinib clinical trials being conducted worldwide. Of these studies, 40 have progressed to the Phase 3 stage of development. While Edmonton is home to a significant portion of those investigations, 10392 other locations around the world are also running similar experiments for this drug."

Answered by AI
~6 spots leftby Mar 2025