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Janus Kinase (JAK) Inhibitor
Ruxolitinib + Thalidomide for Myelofibrosis
Phase 2
Waitlist Available
Led By Raajit Rampal, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the effects of two drugs, ruxolitinib and thalidomide, on cancer. The drugs may help to shrink the cancer, but they may also cause side effects.
Who is the study for?
This trial is for adults with myelofibrosis needing treatment, including those who've had previous treatments or are newly diagnosed with certain risk scores. Participants must be able to take oral meds, have proper organ function, and not be pregnant or breastfeeding. Men and women must use effective birth control. Those already on Ruxolitinib need a stable dose for at least 4 weeks.
What is being tested?
The study is testing the combination of two drugs: Ruxolitinib and Thalidomide, to see if they can shrink myelofibrosis cancer cells effectively. The trial will monitor both the positive outcomes and any adverse side effects from this drug combo.
What are the potential side effects?
Possible side effects include risks associated with each drug individually—Ruxolitinib may cause blood count issues, while Thalidomide can cause drowsiness, constipation, nerve damage (neuropathy), rash or increase the risk of blood clots.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
best objective response rate (ORR)
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%
Haematoma
7%
Dyslipidaemia
7%
Pain in extremity
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%
Bronchitis
3%
Cystitis
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%
Acute pulmonary oedema
2%
Peripheral artery thrombosis
2%
Vertigo
2%
Night sweats
2%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Ureterolithiasis
2%
Localised infection
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: Ruxolitinib and ThalidomideExperimental Treatment2 Interventions
A cohort expansion, for patients with baseline thrombocytopenia, will enroll 35 additional patients
After 3 cycles of ruxolitinib treatment, either prior to study enrollment or through the ruxolitinib run-in phase, patients who meet eligibility criteria will be treated with ruxolitinib and thalidomide orally on days 1-28 of a 28 day cycle. Cycles will be continued until the patient wishes to be removed from the study, unacceptable toxicity develops, disease progression, treating physician recommends removal, or termination of study occurs.
Group II: Cohort A: Ruxolitinib and ThalidomideExperimental Treatment2 Interventions
After 3 cycles of ruxolitinib treatment, either prior to study enrollment or through the ruxolitinib run-in phase, patients who meet eligibility criteria will be treated with ruxolitinib and thalidomide orally on days 1-28 of a 28 day cycle. Cycles will be continued until the patient wishes to be removed from the study, unacceptable toxicity develops, disease progression, treating physician recommends removal, or termination of study occurs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thalidomide
2001
Completed Phase 4
~3050
Ruxolitinib
2018
Completed Phase 3
~1170
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,405 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
391 Previous Clinical Trials
63,805 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
3,066 Previous Clinical Trials
1,802,215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a blood clot in my veins or lungs in the last 6 months.I am 18 years or older.I have been treated with Thalidomide and Ruxolitinib together.I haven't taken cancer drugs other than hydroxyurea or Ruxolitinib recently.You have had a serious allergic reaction to Thalidomide in the past, which caused a rash that peeled off the skin.I only have the cancer this study is targeting, or a non-aggressive cancer that's been treated.I can care for myself and am up and about more than 50% of my waking hours.My organs are functioning well.I am committed to following strict birth control measures and pregnancy testing if I can have children.I am on Ruxolitinib but it's not working well enough for my condition.My total bilirubin level is 2.0 mg/dL or lower, unless I have Gilbert's disease.My liver enzymes are within the allowed range for the trial.I have myelofibrosis needing treatment, regardless of previous treatments or being newly diagnosed with a certain risk level.I have been on a stable dose of Ruxolitinib for at least 4 weeks.I can swallow pills.I am not taking any strong drugs that affect liver enzyme CYP3A4.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Ruxolitinib and Thalidomide
- Group 2: Cohort B: Ruxolitinib and Thalidomide
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.
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