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Tyrosine Kinase Inhibitor

Stopping Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia

Phase 2

Recruiting

Led By Sonali Chaudhury

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Cognitive ability to complete instruments according to the primary team

Patient must be 5 years or older at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of tki discontinuation to the date of the first event (molecular recurrence, hematologic relapse, cytogenetic relapse, re-initiation of tki therapy, second malignant neoplasm, or death) or censoring, assessed up to 2 years

Awards & highlights

Study Summary

This trial will study whether patients with CML in CP can maintain molecular remission after stopping TKI therapy.

Who is the study for?

This trial is for patients diagnosed with chronic myeloid leukemia in chronic phase (CML-CP) who were under 18 at diagnosis, have been in deep molecular remission for at least 2 years, and have taken tyrosine kinase inhibitors (TKIs) for a minimum of 3 years. Participants must be over the age of 8, able to understand English or Spanish, and not pregnant or breastfeeding. Those with certain genetic mutations or additional chromosomal abnormalities are excluded.Check my eligibility

What is being tested?

The study is examining if stopping TKI medication affects the ability to maintain or re-enter molecular remission in CML-CP patients. It involves questionnaire administration, biospecimen collection to monitor disease levels, and quality-of-life assessments after drug withdrawal.See study design

What are the potential side effects?

While specific side effects aren't listed here as it's about drug withdrawal, potential issues may include symptoms related to CML returning or changing due to stopping TKIs. Regular monitoring will help identify any adverse changes early.

Eligibility Criteria

Inclusion Criteria

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

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I can understand and fill out study forms as required.

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I am at least 5 years old.

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My leukemia is in remission with very low BCR-ABL1 levels for 2+ years.

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I was diagnosed with chronic myeloid leukemia in its chronic phase before I turned 18.

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I have not been diagnosed with a neurodevelopmental disorder before my CML diagnosis.

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I agree to stop taking TKI medication.

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I am 8 years old or older.

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My original diagnosis was confirmed as chronic myeloid leukemia in the chronic phase.

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I have been on a TKI medication for at least 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of tki discontinuation to the date of the first event (molecular recurrence, hematologic relapse, cytogenetic relapse, re-initiation of tki therapy, second malignant neoplasm, or death) or censoring, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of tki discontinuation to the date of the first event (molecular recurrence, hematologic relapse, cytogenetic relapse, re-initiation of tki therapy, second malignant neoplasm, or death) or censoring, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of tki discontinuation to the date of the first event (molecular recurrence, hematologic relapse, cytogenetic relapse, re-initiation of tki therapy, second malignant neoplasm, or death) or censoring, assessed up to 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

Major molecular remission (MMR/MR3)

Treatment-free remission (TFR)

Secondary outcome measures

Clinical factors and laboratory correlates affecting persistence of MMR

Trial Design

1Treatment groups

Experimental Treatment

Group I: Basic Science (stop taking TKI, biospecimen collection)Experimental Treatment5 Interventions

Patients stop taking TKI medication within 10 days after enrollment. Patients undergo peripheral blood collection to monitor loss of MMR every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3. Patients who lose their molecular remission may restart TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

454 Previous Clinical Trials

237,830 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,744 Total Patients Enrolled

Sonali ChaudhuryPrincipal InvestigatorChildren's Oncology Group

Media Library

Tyrosine Kinase Inhibitor (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03817398 — Phase 2

Chronic Myeloid Leukemia Research Study Groups: Basic Science (stop taking TKI, biospecimen collection)

Chronic Myeloid Leukemia Clinical Trial 2023: Tyrosine Kinase Inhibitor Highlights & Side Effects. Trial Name: NCT03817398 — Phase 2

Tyrosine Kinase Inhibitor (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03817398 — Phase 2

Frequently Asked Questions

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

Has the FDA cleared Tyrosine Kinase Inhibitor for therapeutic use?

"While Phase 2 trials don't have the same robust efficacy data as later stages, our team has assessed the safety of Tyrosine Kinase Inhibitor to be a 2."

Answered by AI

Are patients being enrolled in this trial at this time?

"The study, which can be found on clinicaltrials.gov, is looking for participants and was last edited on 10/19/2022."

Answered by AI

What diseases does Tyrosine Kinase Inhibitor help alleviate symptoms for?

"Tyrosine Kinase Inhibitors are often used to treat renal dysfunction, but they have also been effective in interventions for amino acid supplementation, kidney failure, and acute coryza."

Answered by AI

Can you tell me how many places are participating in this experiment?

"Out of the 100 available sites, this study is currently recruiting patients from locations such as Allentown, Mesa and Chicago. It would be convenient to select a trial site near you in order to limit travel time and expenses."

Answered by AI

What other types of medical trials are similar to this one?

"Tyrosine Kinase Inhibitor has been under clinical investigation since 2007. The initial trial was sponsored by Baxter Healthcare Corporation and took place in that same year. 4640 patients were involved in the first study which resulted in Tyrosine Kinase Inhibitor receiving Phase 4 drug approval. There are currently 47 active trials for Tyrosine Kinase Inhibitor being conducted across 1094 cities in 14 countries."

Answered by AI

Are Tyrosine Kinase Inhibitors a common treatment in other clinical trials?

"Tyrosine Kinase Inhibitors were first researched in 2007 at Surgical Intensive Care Unit Regional Hospital Jessa. As of now, 268 clinical trials have been completed with 47 more ongoing studies. Most of these live clinical trials are being conducted out of Allentown, Pennsylvania."

Answered by AI

How many people are expected to sign up for this clinical trial?

"The information available on clinicaltrials.gov indicates that this trial is still recruiting patients as of October 19th, 2022. The study was initially posted on July 15th, 2019. One hundred and ten patients are needed for the study which is taking place at one hundred locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia

2019. "Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03817398.

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