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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

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My lymphoma is confirmed to be T or NK cell type, and if it's CTCL, it's stage IB or higher.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I am on entecavir or similar medication for hepatitis B, and my PCR test is negative.

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I am 18 years old or older.

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My blood or bone marrow has abnormal or cancerous white blood cells.

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My lymphoma is classified according to the Lugano system.

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My skin cancer shows signs of spreading or I have a high number of specific cancer cells in my blood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Dyslipidaemia

Pain in extremity

Haematoma

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Paraesthesia

Cystitis

Bronchitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Localised infection

Intervertebral disc protrusion

Urethral stenosis

Night sweats

Acute pulmonary oedema

Vertigo

Peripheral artery thrombosis

Ureterolithiasis

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

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

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,816 Total Patients Enrolled

155 Trials studying Lymphoma

8,657 Patients Enrolled for Lymphoma

Cornell UniversityOTHER

166 Previous Clinical Trials

14,089,778 Total Patients Enrolled

Dana-Farber Cancer InstituteOTHER

1,079 Previous Clinical Trials

340,898 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: with rel/ref PTCL with functional evidence of JAK/STAT, Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations., 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which afflictions is Ruxolitinib typically prescribed?

"Ruxolitinib is traditionally utilized for the treatment of polycythemia vera, but can also be useful in managing hydroxyurea-resistant or -intolerant cases of polycythemia and primary myelofibrosis."

Answered by AI

Is enrollment still available for this clinical investigation?

"According to the data hosted on clinicaltrials.gov, this research is actively searching for participants. The initial posting was made on November 1st 2016 and it has just been updated October 5th 2022."

Answered by AI

Has Ruxolitinib been granted authorization from the FDA?

"This Phase 2 trial has some evidence affirming its safety, thus receiving a score of two. However, there is yet to be any data confirming the efficacy of Ruxolitinib."

Answered by AI

Are there any prior investigations that have utilized Ruxolitinib?

"Ruxolitinib was first evaluated in 2002 at the National Institutes of Health Clinical Center located on Rockville Pike. As of now, 93 trials have been finished and 97 are actively recruiting for participants; a significant proportion being hosted out of Uniondale, New york."

Answered by AI

How many healthcare facilities are presently conducting this experiment?

"Across 8 different facilities, this trial is recruiting patients. For example, Memorial Sloan Kettering Nassau (All Protocol Activities) in Uniondale, Memorial Sloan Kettering Monmouth (All Protocol Activities)in Middletown and Memorial Sloan Kettering Commack in Commack are just a few of the participating medical sites."

Answered by AI

How extensive is the population sample of this medical experiment?

"This clinical trial requires 82 individuals to enroll, all of whom must meet the particular inclusion criteria. Potential participants can apply from Memorial Sloan Kettering's Nassau and Monmouth locations in Uniondale, New york as well as Middletown, New jersey respectively."

Answered by AI

Recent research and studies

BloodJournal

A Phase 2 Biomarker-driven Study of Ruxolitinib Demonstrates Effectiveness of JAK/STAT Targeting in T-cell Lymphomas

Moskowitz, Alison J., Paola Ghione, Eric Jacobsen, Jia Ruan, Jonathan H. Schatz, Sarah Noor, Patricia Myskowski, et al.. 2021. “A Phase 2 Biomarker-driven Study of Ruxolitinib Demonstrates Effectiveness of JAK/STAT Targeting in T-cell Lymphomas”. Blood. American Society of Hematology. doi:10.1182/blood.2021013379.

BloodJournal

A Phase 2 Biomarker-driven Study of Ruxolitinib Demonstrates Effectiveness of JAK/STAT Targeting in T-cell Lymphomas

clinicaltrials.govStudy

Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma

2016. "Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02974647.

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