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JAK Inhibitor

Ruxolitinib for Lymphoma

Phase 2
Recruiting
Led By Alison Moskowitz, MD
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
Pathologically confirmed T or NK cell lymphoma at the enrolling institution. For CTCL, patients with stage IB disease or greater are eligible.
ECOG ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing if ruxolitinib can help people with certain types of cancer by blocking a protein called JAK that is important for the survival of many T or NK-cell lymphomas.

Who is the study for?
Adults with relapsed or refractory T or NK cell lymphoma who've had at least one prior systemic therapy can join this trial. They must have measurable disease, adequate blood counts, and organ function. Those with HIV may participate if treated and without active infections. Pregnant women, individuals in poor health, or those on certain other treatments are excluded.Check my eligibility
What is being tested?
The trial is testing Ruxolitinib's effectiveness for shrinking T or NK-cell lymphomas by blocking a protein called JAK that helps these cancer cells survive. Participants will receive Ruxolitinib to see how well it works against their lymphoma.See study design
What are the potential side effects?
Ruxolitinib might cause side effects like anemia (low red blood cell count), low platelet count which affects clotting, liver enzyme changes indicating potential liver issues, and possibly increased risk of infection due to its immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lymphoma is confirmed to be T or NK cell type, and if it's CTCL, it's stage IB or higher.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I am on entecavir or similar medication for hepatitis B, and my PCR test is negative.
Select...
I am 18 years old or older.
Select...
My blood or bone marrow has abnormal or cancerous white blood cells.
Select...
My lymphoma is classified according to the Lugano system.
Select...
My skin cancer shows signs of spreading or I have a high number of specific cancer cells in my blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
disease control rate

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036
33%
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%
Cystitis
3%
Bronchitis
3%
Blood creatine phosphokinase increased
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%
Vertigo
2%
Localised infection
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
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

4Treatment groups
Experimental Treatment
Group I: with rel/ref PTCL with functional evidence of JAK/STATExperimental Treatment1 Intervention
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
Group II: with rel/ref PTCL who do not meet criteria for cohort 1 or 2.Experimental Treatment1 Intervention
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours).Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
Group III: rel/ref PTCLtumors are known to contain mutations associExperimental Treatment1 Intervention
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
Group IV: Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations.Experimental Treatment1 Intervention
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
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?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,941 Previous Clinical Trials
588,866 Total Patients Enrolled
155 Trials studying Lymphoma
8,638 Patients Enrolled for Lymphoma
Cornell UniversityOTHER
167 Previous Clinical Trials
14,089,898 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,081 Previous Clinical Trials
340,900 Total Patients Enrolled
59 Trials studying Lymphoma
2,304 Patients Enrolled for Lymphoma

Media Library

Ruxolitinib (JAK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02974647 — Phase 2
Lymphoma Research Study Groups: Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations., with rel/ref PTCL with functional evidence of JAK/STAT, rel/ref PTCLtumors are known to contain mutations associ, with rel/ref PTCL who do not meet criteria for cohort 1 or 2.
Lymphoma Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT02974647 — Phase 2
Ruxolitinib (JAK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02974647 — Phase 2
~3 spots leftby Nov 2024
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