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Tyrosine Kinase Inhibitor

Ruxolitinib + Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia

Phase 2

Waitlist Available

Led By Kendra L Sweet

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have detectable BCR-ABL transcripts measured by reverse transcriptase (RT)-PCR at a clinical laboratory improvement act (CLIA)-approved laboratory and reported on the international scale (IS) with a value of > 0.0032% IS and =< 1.0% IS within 21 days prior to randomization

Patients must be currently receiving treatment with bosutinib, nilotinib, dasatinib, or imatinib within specified dose ranges

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the different tyrosine kinase inhibitors, with and without ruxolitinib, to see how well they work in treating patients with chronic myeloid leukemia.

Who is the study for?

This trial is for chronic myeloid leukemia patients who've been on tyrosine kinase inhibitors (TKI) like bosutinib, dasatinib, imatinib or nilotinib for at least a year. They should have stable vital signs and organ function, not be pregnant or breastfeeding, agree to use contraception, and not have HIV with detectable viral loads. Prior cancer is okay if no active treatment is needed.

What is being tested?

The study tests adding Ruxolitinib—a drug that blocks growth factors necessary for leukemia cells—to the usual TKI treatments. It's a phase II randomized trial aiming to see if this combination better reduces leukemia cell counts compared to TKI alone.

What are the potential side effects?

Ruxolitinib may cause side effects such as low blood counts leading to increased infection risk, bleeding problems, dizziness or headaches. Other possible issues include liver enzyme changes and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BCR-ABL levels are between 0.0032% and 1.0% as confirmed by a recent test.

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I am currently on treatment with specific targeted cancer drugs.

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My heart's electrical activity is normal as per my recent EKG.

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I have been on TKI treatment for my CML for at least a year.

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I have never had a drug resistance to TKI medication.

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My white blood cell count is healthy.

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I have chronic myeloid leukemia in the chronic phase without it worsening.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

BCR-ABL/BCR analysis

Drug compliance

Incidence of adverse events

+4 more

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (ruxolitinib phosphate, dasatinib, nilotinib, imatinib)Experimental Treatment5 Interventions

Patients receive ruxolitinib phosphate PO BID on days 1-90, and bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (bosutinib, dasatinib, nilotinib, imatinib)Active Control5 Interventions

Patients receive bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imatinib

2011

Completed Phase 3

~3940

Dasatinib

2012

Completed Phase 3

~2320