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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

Must not have

Prior therapy with ruxolitinib

ECOG performance status >2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with ruxolitinib before.

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I need help with my daily activities due to my health condition.

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I do not have any severe illnesses that could interfere with the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Haematoma

Dyslipidaemia

Pain in extremity

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

Bronchitis

Cystitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Acute pulmonary oedema

Peripheral artery thrombosis

Vertigo

Night sweats

Intervertebral disc protrusion

Urethral stenosis

Ureterolithiasis

Localised infection

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1170

0 / 10Eligibility criteria met