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Tyrosine Kinase Inhibitor

Ruxolitinib + TKI for CML

Phase 2
Recruiting
Led By Kendra Sweet, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
After first failed TFR attempt, must have a minimum duration of 1 year on a TKI, and must plan to remain on this same TKI for a minimum of 12 months during the combination treatment phase
Diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR-ABL protein
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study Summary

This trial is testing if adding Ruxolitinib to a TKI will help people with CML achieve TFR.

Who is the study for?
This trial is for individuals with chronic phase Chronic Myeloid Leukemia (CML) who have tried to stop taking their Tyrosine Kinase Inhibitor (TKI) once before but saw their disease return. They must be in stable condition, not resistant to TKIs, and meet specific criteria regarding previous treatment responses and current health status.Check my eligibility
What is being tested?
The study aims to see if adding Ruxolitinib to a patient's current TKI therapy can help them achieve a prolonged period where they don't need any treatment at all after stopping the TKI for the second time.See study design
What are the potential side effects?
Potential side effects of Ruxolitinib may include blood count changes, risk of infection, liver function alterations, and other issues that could affect various organs. The exact side effects will vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've been on a TKI for at least 1 year after my first treatment failure and plan to stay on it.
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I have chronic phase CML with specific genetic variants.
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I have tried stopping my TKI treatment once before with my doctor's advice.
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I can care for myself but may not be able to do heavy physical work.
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I have been treated with a specific cancer drug for at least 3 years.
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My blood cancer has been stable for over 2 years, confirmed by 4 tests.
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I am currently taking the same TKI medication as I did before my first TFR attempt.
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My cancer returned after stopping my first TKI treatment.
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My latest lab results show very low levels of BCR-ABL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12 Month Treatment Free Remission (TFR)
Secondary outcome measures
Adverse Events Possibly Related to Study Treatment
Other outcome measures
Incidence of Improved Scores in Health Related Quality of Life Questionnaire

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination Therapy + Remission PhaseExperimental Treatment2 Interventions
Combination therapy followed by treatment free remission (TFR) phase. Combination Therapy: Ruxolitinib plus BCR-ABL Tyrosine Kinase Inhibitors (TKIs). All eligible patients will begin ruxolitinib in combination with their BCR-ABL TKI on cycle 1 day 1 of the combination phase. For cycle 2 and beyond, if day 1 of a cycle is delayed, day 1 procedures should be repeated if out of the specified window and day 1 of the cycle is considered the day study drug is restarted. They will continue combination therapy for a total of 12 cycles. Each cycle will be approximately 28 days. At the end of 12 cycles ruxolitinib will be discontinued and any patient who has met the criteria for the treatment free remission (TFR) screening phase will enter into the TFR phase. Once in the TFR phase, participants will discontinue their BCR-ABL TKI and be monitored off treatment.
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?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,441 Total Patients Enrolled
H. Jean Khoury Cure CML ConsortiumOTHER
2 Previous Clinical Trials
59 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,114 Total Patients Enrolled

Media Library

BCR-ABL Tyrosine Kinase Inhibitor (TKI) (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03610971 — Phase 2
Chronic Myeloid Leukemia Research Study Groups: Combination Therapy + Remission Phase
Chronic Myeloid Leukemia Clinical Trial 2023: BCR-ABL Tyrosine Kinase Inhibitor (TKI) Highlights & Side Effects. Trial Name: NCT03610971 — Phase 2
BCR-ABL Tyrosine Kinase Inhibitor (TKI) (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03610971 — Phase 2

Frequently Asked Questions

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

At how many venues is this investigation being managed?

"This research initiative is currently being conducted at 8 distinct sites, located in Atlanta, Seattle and Milwaukee among other cities. In order to minimise travel time for participants, it's recommended that they choose a nearby centre."

Answered by AI

What potential hazards come with the application of BCR-ABL Tyrosine Kinase Inhibitor (TKI) medication?

"There is limited clinical data that supports the safety of BCR-ABL Tyrosine Kinase Inhibitors (TKI), prompting it to receive a score of 2. Nonetheless, further research needs to be conducted before any evidence can confirm efficacy."

Answered by AI

For what maladies is BCR-ABL Tyrosine Kinase Inhibitor (TKI) typically prescribed?

"BCR-ABL Tyrosine Kinase Inhibitors (TKIs) are commonly used to help mitigate symptoms associated with amino acid supplementation, polycythemia vera, and polycythemia."

Answered by AI

Has any other investigation been done with the BCR-ABL Tyrosine Kinase Inhibitor (TKI) yet?

"The National Institutes of Health Clinical Center in Rockville Pike, Maryland was the origin point for BCR-ABL Tyrosine Kinase Inhibitor (TKI) research back in 2002. As of now, 144 studies are actively recruiting and 131 have already been completed. A large portion of these trials is taking place in Atlanta, Georgia."

Answered by AI

Is this research initiative currently open to enrolling participants?

"Affirmative. According to the clinicaltrials.gov database, this medical study has been actively recruiting since its posting on November 19th 2019 and was last refreshed on July 26th 2022. 51 participants need to be recruited from 8 different sites for completion of this trial."

Answered by AI

How many individuals are enrolled in this clinical investigation?

"To effectively investigate the efficacy of this medical trial, 51 volunteers must be recruited who meet the necessary inclusion criteria. Potential participants can join from multiple locations such as Emory-Winship Cancer Institute in Atlanta or Fred Hutchinson Cancer Research Centre in Seattle."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors
2019. "Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03610971.
~7 spots leftby Jan 2025
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