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Janus Kinase (JAK) Inhibitor
Ruxolitinib for Chronic Myelomonocytic Leukemia
Phase 2
Waitlist Available
Led By Eric Padron, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have symptomatic splenomegaly and/or a Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score >17
Confirmed diagnosis of Chronic Myelomonocytic Leukemia (CMML) using the World Health Organization (WHO) classification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing whether a specific drug can help people with a certain type of leukemia.
Who is the study for?
Adults diagnosed with Chronic Myelomonocytic Leukemia (CMML) who can attend scheduled visits, provide bone marrow samples, and have a life expectancy over 3 months. They must not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and have an ECOG score of 0-2. Excluded are those with certain blood abnormalities, recent chemotherapy or experimental treatments, uncontrolled illnesses like heart failure or severe infections.Check my eligibility
What is being tested?
The trial is testing Ruxolitinib's effectiveness in improving outcomes for patients with CMML. It involves taking the study drug under supervision to see if it helps manage symptoms better than current standard treatments.See study design
What are the potential side effects?
Ruxolitinib may cause side effects such as low blood cell counts leading to increased infection risk, bleeding problems, kidney function changes, liver issues indicated by elevated bilirubin levels. Specific side effect experiences can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a large spleen and/or severe symptoms from my blood disorder.
Select...
I have been diagnosed with Chronic Myelomonocytic Leukemia.
Select...
I can provide bone marrow samples for testing.
Select...
I am able to care for myself and perform daily activities.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response
Secondary outcome measures
Duration of Response
Overall Survival
Time to Acute Myeloid Leukemia (AML) Transformation
Other outcome measures
Change in symptom score
Mutational Status
Pathological Response
Side effects data
From 2020 Phase 3 trial • 149 Patients • NCT0203803633%
Anaemia
19%
Hypertension
17%
Nasopharyngitis
16%
Weight increased
14%
Herpes zoster
14%
Constipation
14%
Abdominal pain
14%
Headache
12%
Pruritus
12%
Back pain
12%
Epistaxis
12%
Pyrexia
12%
Dizziness
10%
Asthenia
10%
Fatigue
10%
Cough
10%
Oedema peripheral
10%
Arthralgia
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Blood creatine phosphokinase increased
3%
Cystitis
3%
Bronchitis
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Localised infection
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: RuxolitinibExperimental Treatment1 Intervention
All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,136 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,463 Total Patients Enrolled
Eric Padron, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a large spleen and/or severe symptoms from my blood disorder.I am using GM-CSF or have used G-CSF for infection due to low neutrophils.I do not have any uncontrolled illnesses that could affect my study participation.I agree to use two forms of birth control or abstain from sex during the study.I am not pregnant or breastfeeding if considering ruxolitinib treatment.I have been diagnosed with Chronic Myelomonocytic Leukemia.I can provide bone marrow samples for testing.I have had cancer spread to other parts of my body in the last 2 years.I haven't used any strong cancer drugs or experimental treatments for my CMML in the last 28 days.I am able to care for myself and perform daily activities.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being recruited to take part in this research?
"As of this moment, no participants are being recruited for the study. It was first posted on August 28th 2019 and last updated November 11th 2022. If you're looking elsewhere, 1421 clinical trials require individuals with leukemia while 97 studies need patients taking Ruxolitinib medications."
Answered by AI
What is the enrollment status of this clinical trial?
"Per the information on clinicaltrials.gov, this medical trial is not presently attempting to enlist volunteers. Initially posted on August 28th 2019 and last modified November 11th 2022, it has since ceased seeking out potential candidates. Nevertheless, there are 1,518 other studies actively recruiting participants at present."
Answered by AI
What conditions is Ruxolitinib most frequently employed to combat?
"Ruxolitinib is widely employed to manage polycythemia vera and related disorders such as hydroxyurea-resistant/intolerant polycythemia, primary myelofibrosis."
Answered by AI
How prevalent is this medical research being conducted in Canada?
"Patients will have the opportunity to participate in this trial at H. Lee Moffitt Cancer Center and Research Institute, located in Tampa, Florida; Dana Farber Cancer Institute near Boston, Massachusetts; or Johns Hopkins Sidney Kimmel Comprehensive Cancer Center close to New york City. Moreover, 6 other clinical sites are involved as well."
Answered by AI
What precedent has been established by previous experiments involving Ruxolitinib?
"Ruxolitinib has been studied since 2002, with 93 completed trials and 97 currently in process. The original research was conducted at National Institutes of Health Clinical Center located on 9000 Rockville Pike Road, while many ongoing studies are being held out of Tampa, Florida."
Answered by AI
Has Ruxolitinib been sanctioned for clinical use by the FDA?
"Our team at Power has assigned a rating of 2 to ruxolitinib's safety, as this trial is still in Phase 2 and the data so far only supports its security rather than efficacy."
Answered by AI
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