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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

Must not have

Female patients who are pregnant

Additional clonal chromosomal abnormalities in Philadelphia chromosome (Ph) positive (+) cells at any time prior to enrollment that include 'major route' abnormalities (second Ph, trisomy 8, isochromosome 17q, trisomy 19), complex karyotype or abnormalities of 3q26.2

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

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant.

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My cancer has specific genetic changes known as 'major route' abnormalities.

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I am not pregnant or have confirmed it with a negative pregnancy test.

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My chronic myeloid leukemia has been in an advanced stage.

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My cancer has the T3151 mutation.

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

~1720

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

456 Previous Clinical Trials

239,677 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,748 Previous Clinical Trials

40,959,291 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

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