Ruxolitinib for Leukemia, Myeloid

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Leukemia, Myeloid+6 More
Ruxolitinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Leukemia, Myeloid
  • Myeloid Leukemia
  • Leukemia, Myelocytic, Acute

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Myeloid

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: From first PR or better to loss of best response, or date of last assessment (up to 24 months)

Month 12
Overall survival
Month 24
Duration of response
Day 30
Overall incidence of treatment-related and non-treatment related toxicity
Day 36
Clinical benefit rate (CBR)
Composite complete remission rate
Month 12
Event-free survival
Up to day 56
Dose-limiting toxicities (DLT) of ruxolitinib and venetoclax in combination

Trial Safety

Safety Progress

1 of 3

Other trials for Leukemia, Myeloid

Side Effects for

Best Available Therapy
23%Pruritus
12%Headache
9%Diarrhoea
9%Upper respiratory tract infection
8%Thrombocytopenia
8%Asthenia
8%Fatigue
7%Dizziness
7%Nausea
7%Night sweats
7%Haematocrit increased
5%Leukocytosis
5%Constipation
5%Influenza
5%Decreased appetite
5%Erythema
5%Weight decreased
4%Arthralgia
4%Hypertension
4%Abdominal pain upper
4%Thrombocytosis
3%Tinnitus
3%Abdominal discomfort
3%Dyspepsia
3%Oedema peripheral
3%Nasopharyngitis
3%Myalgia
3%Pain in extremity
3%Cough
3%Dyspnoea
3%Epistaxis
3%Bronchitis
1%Anaemia
1%Atrial fibrillation
1%Gastrointestinal haemorrhage
1%Rectal haemorrhage
1%Cellulitis
1%Hyponatraemia
1%Bladder transitional cell carcinoma
1%Syncope
1%Extremity necrosis
1%Abdominal pain
1%Pyrexia
1%Flatulence
1%Blood lactate dehydrogenase increased
1%Gamma-glutamyltransferase increased
1%Musculoskeletal pain
1%Hyperuricaemia
1%Osteoarthritis
1%Haematoma
1%Pneumonia
1%Septic shock
1%Neutropenia
1%Meningitis
1%Vertigo
1%Depression
1%Myelofibrosis
1%Respiratory failure
1%Abdominal distension
1%Vomiting
1%Weight increased
1%Muscle spasms
1%Acute myeloid leukaemia
1%Breast cancer
1%Cardiac failure
1%Renal failure
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02038036) in the Best Available Therapy ARM group. Side effects include: Pruritus with 23%, Headache with 12%, Diarrhoea with 9%, Upper respiratory tract infection with 9%, Thrombocytopenia with 8%.

Trial Design

1 Treatment Group

Treatment (ruxolitinib, venetoclax)
1 of 1
Experimental Treatment

31 Total Participants · 1 Treatment Group

Primary Treatment: Ruxolitinib · No Placebo Group · Phase 1

Treatment (ruxolitinib, venetoclax)Experimental Group · 2 Interventions: Ruxolitinib, Venetoclax · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved
Venetoclax
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from first pr or better to loss of best response, or date of last assessment (up to 24 months)

Who is running the clinical trial?

Brian DrukerLead Sponsor
Oregon Health and Science UniversityOTHER
885 Previous Clinical Trials
6,828,510 Total Patients Enrolled
6 Trials studying Leukemia, Myeloid
121 Patients Enrolled for Leukemia, Myeloid
AbbVieIndustry Sponsor
822 Previous Clinical Trials
469,574 Total Patients Enrolled
39 Trials studying Leukemia, Myeloid
5,191 Patients Enrolled for Leukemia, Myeloid
Incyte CorporationIndustry Sponsor
309 Previous Clinical Trials
46,281 Total Patients Enrolled
5 Trials studying Leukemia, Myeloid
200 Patients Enrolled for Leukemia, Myeloid
Jennifer Saultz, MDPrincipal InvestigatorOHSU Knight Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Creatinine clearance is 30 mL/min or greater.
Total serum bilirubin =< 1.5 x ULN.
You are able to understand the nature and purpose of the study and are willing to sign a written informed consent document.
You have a performance status of 0 to 2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.