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Janus Kinase (JAK) Inhibitor
Ruxolitinib for Large Granular Lymphocytic Leukemia
Phase 2
Recruiting
Led By John Reneau, MD
Research Sponsored by John Reneau
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 up to 12 months
Awards & highlights
Study Summary
This trial tests if a drug can shrink tumors in patients with a rare form of leukemia. The drug may stop cancer cell growth by blocking enzymes.
Who is the study for?
Adults with T-cell large granular lymphocyte leukemia (T-LGLL) who have tried at least one treatment without success and are not currently on therapy. They must have symptoms like low hemoglobin, need regular blood transfusions, or suffer from frequent infections due to low neutrophil counts. Their liver and kidney functions should be near normal, they can't be pregnant, and must agree to use birth control.Check my eligibility
What is being tested?
The trial is testing Ruxolitinib's effectiveness in shrinking tumors for patients with T-LGLL. It's a phase II study where the drug aims to inhibit enzymes that cancer cells need to grow.See study design
What are the potential side effects?
Ruxolitinib may cause side effects such as infection risk due to lowered immune response, anemia, changes in liver enzyme levels indicating potential liver issues, and possibly other reactions related to altering cell growth processes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Incidence of treatment-emergent adverse events
Leukemia-free survival (LFS)
Patient quality-of-life (QOL) EORTC
+3 moreSide 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%
Paraesthesia
3%
Cystitis
3%
Bronchitis
3%
Blood creatine phosphokinase increased
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%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
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: Treatment (ruxolitinib)Experimental Treatment1 Intervention
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients who achieve a response (CR or PR) may receive an additional 12 months of ruxolitinib, for a maximum of 24 months.
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?
John ReneauLead Sponsor
3 Previous Clinical Trials
59 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,139 Total Patients Enrolled
John Reneau, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
47 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms of anemia with low hemoglobin levels.I have low white blood cell counts and get infections often.I can perform daily activities with minimal assistance.My kidney function is severely reduced.I agree to use effective birth control during the study.I have not had a heart attack or unstable chest pain in the last 2 months.I have been diagnosed with a specific type of leukemia and meet the cell count criteria.I need regular blood transfusions for my anemia.I need treatment for T-LGL leukemia.I am currently experiencing a flare-up of my lung condition.I have untreated T-cell large granular lymphocytic leukemia.I do not have an active infection needing treatment, nor HIV or hepatitis B/C.I am 18 years old or older.I have no active cancer besides T-LGLL or early stage skin/prostate cancer not needing treatment.I am on a low dose of steroids for an autoimmune condition or to treat T-LGL symptoms.I have tried at least one treatment for my condition and stopped it more than 14 days ago or 5 half-lives ago, whichever is longer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
Has the FDA green-lighted ruxolitinib as a therapy?
"Ruxolitinib was scored a 2 on the safety scale due to its status as a Phase 2 trial, which indicates there is evidence of safety but no efficacy data."
Answered by AI
Are there still vacancies for participants in this trial?
"According to clinicaltrials.gov, the window for enrolling in this trial has passed; last updated on October 20th 2022 and originally posted December 1st 2022. However, there are still 1454 other medical studies actively seeking participants at this time."
Answered by AI
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