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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 a diagnosis of chronic phase chronic myeloid leukemia without any history of progression to accelerated or blast phase CML; no new bone marrow aspiration and biopsy is needed to prove diagnosis prior to randomization; however, documentation stating the patient is in chronic phase is required
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; the RT-PCR assay must have the sensitivity to detect a 4.5 log reduction in BCR-ABL transcripts from 100% IS (0.0032% IS or lower)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Study 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.Check my eligibility
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.See study design
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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I have chronic myeloid leukemia in the chronic phase without it getting worse.
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My BCR-ABL levels are between 0.0032% and 1.0% as measured by a specific blood test.
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I have been on TKI treatment for my CML for over a year.
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I've been on a specific cancer treatment for at least 6 months and will continue for another year.
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I have not been resistant to previous TKI cancer treatments.
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I had a full medical check-up in the last 28 days.
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My heart's electrical activity is normal as per my recent EKG test.
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My white blood cell count is above the required level.
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My liver tests, ALT and AST, are within normal limits.
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My bilirubin levels are normal or slightly elevated, but I might have Gilbert's syndrome.
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I have had cancer before, but it doesn't need treatment now. Hormone therapy is okay.
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I am not pregnant or nursing and will use effective birth control during and after the study.
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My blood test for BCR-ABL was done in a certified lab within the last 21 days.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of molecular response 4.5 (MR4.5)
Secondary outcome measures
BCR-ABL/BCR analysis
Drug compliance
Incidence of adverse events
+4 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036
23%
Pruritus
12%
Headache
9%
Diarrhoea
9%
Upper respiratory tract infection
8%
Fatigue
8%
Asthenia
8%
Thrombocytopenia
7%
Nausea
7%
Dizziness
7%
Night sweats
7%
Haematocrit increased
5%
Influenza
5%
Weight decreased
5%
Erythema
5%
Decreased appetite
5%
Leukocytosis
5%
Constipation
4%
Thrombocytosis
4%
Abdominal pain upper
4%
Arthralgia
4%
Hypertension
3%
Dyspnoea
3%
Oedema peripheral
3%
Bronchitis
3%
Epistaxis
3%
Abdominal discomfort
3%
Tinnitus
3%
Nasopharyngitis
3%
Myalgia
3%
Dyspepsia
3%
Pain in extremity
3%
Cough
1%
Depression
1%
Vertigo
1%
Weight increased
1%
Haematoma
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Syncope
1%
Respiratory failure
1%
Abdominal pain
1%
Neutropenia
1%
Muscle spasms
1%
Anaemia
1%
Rectal haemorrhage
1%
Cellulitis
1%
Meningitis
1%
Pneumonia
1%
Septic shock
1%
Hyponatraemia
1%
Acute myeloid leukaemia
1%
Bladder transitional cell carcinoma
1%
Breast cancer
1%
Myelofibrosis
1%
Extremity necrosis
1%
Abdominal distension
1%
Flatulence
1%
Vomiting
1%
Pyrexia
1%
Blood lactate dehydrogenase increased
1%
Gamma-glutamyltransferase increased
1%
Hyperuricaemia
1%
Musculoskeletal pain
1%
Osteoarthritis
1%
Cardiac failure
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Best Available Therapy
All Crossover Patients
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 2
~2200
Nilotinib
2005
Completed Phase 4
~2670
Ruxolitinib
2018
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,526 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
262,167 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,565 Previous Clinical Trials
41,223,716 Total Patients Enrolled

Media Library

Bosutinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03654768 — Phase 2
Chronic Myelogenous Leukemia Research Study Groups: Arm I (bosutinib, dasatinib, nilotinib, imatinib), Arm II (ruxolitinib phosphate, dasatinib, nilotinib, imatinib)
Chronic Myelogenous Leukemia Clinical Trial 2023: Bosutinib Highlights & Side Effects. Trial Name: NCT03654768 — Phase 2
Bosutinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03654768 — Phase 2

Frequently Asked Questions

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

Are there multiple research sites conducting this investigation in North America?

"This study, which currently has 100 slots open for enrolment, is recruiting at the Vince Lombardi Cancer Clinic-Sheboygan in Sheboygan, Oregon Health and Science University in Portland, Swedish Cancer Institute-Edmonds in Edmonds, amongst other medical centres."

Answered by AI

Could you provide a synopsis of past research involving Ruxolitinib Phosphate?

"Currently, 185 clinical trials are running to explore the effects of Ruxolitinib Phosphate. Among those studies, 25 have progressed to Phase 3 and over 7500 different sites worldwide are recruiting for these experiments. Specifically, Fukuoka City in Japan holds a plethora of such research initiatives."

Answered by AI

How many participants are being included in this trial?

"This clinical trial mandates the involvement of 84 participants with qualifying characteristics. At Vince Lombardi Cancer Clinic-Sheboygan in Sheboygan, Wisconsin and Oregon Health and Science University in Portland, Oregon, potential candidates can join this medical research project."

Answered by AI

What sort of risks does Ruxolitinib Phosphate pose to individuals undergoing treatment?

"The safety of Ruxolitinib Phosphate has been estimated as a 2 on our company's scale, due to the clinical evidence that exists supporting its security but not yet demonstrating effectiveness."

Answered by AI

Is this experiment actively searching for new participants?

"As detailed on the clinicaltrials.gov website, recruitment is in progress for this medical research trial which was initially posted on October 24th 2018 and amended as recently as May 3rd 2022."

Answered by AI

What conditions is Ruxolitinib Phosphate typically employed to treat?

"Ruxolitinib Phosphate is known to be a viable treatment option for polycythemia vera. Patients with hydroxyurea-resistant or -intolerant polycythemia, as well as those struggling with primary myelofibrosis, can also benefit from this medication."

Answered by AI
~5 spots leftby Jul 2024