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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
Patient must have received any TKI for a minimum of 3 consecutive years at time of enrollment
No known history of neurodevelopmental disorder prior to diagnosis of CML (e.g., Down syndrome, Fragile X, William syndrome, mental retardation)
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
No Placebo-Only Group

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 have been on a TKI medication for at least 3 years.
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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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My original diagnosis was confirmed as chronic myeloid leukemia in the chronic phase.
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I can understand English or Spanish.
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I am 8 years old or older.
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My lab tests meet the required standards and can report results quickly.
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I speak English, French, or Spanish.
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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 can understand and fill out study forms as required.
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I am at least 5 years old.

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
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 1
~1850

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,065 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,584 Previous Clinical Trials
41,240,008 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
~39 spots leftby Jun 2026