Stopping Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia

Recruiting at182 trial locations

Overseen by Sonali Chaudhury

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.

Research Team

Sonali Chaudhury

Principal Investigator

Children's Oncology Group

Eligibility Criteria

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.

Inclusion Criteria

All patients and/or their parents or legal guardians must sign a written informed consent

No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

Lactating females are not eligible unless they have agreed not to breastfeed their infants

I am currently pregnant.

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

Treatment Details

Interventions

• Drug Withdrawn (Other)
• Tyrosine Kinase Inhibitor (Tyrosine Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Basic Science (stop taking TKI, biospecimen collection) Experimental Treatment 5 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.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

Dr. Doug Hawkins

Children's Oncology Group

Chief Executive Officer since 2020

MD from University of Washington School of Medicine

Dr. Leo Mascarenhas

Children's Oncology Group

Chief Medical Officer since 2024

MD, MS from Cedars-Sinai Guerin Children’s

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School