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Tyrosine Kinase Inhibitor

TKI Cessation for Chronic Myeloid Leukemia (TOKIN Trial)

Phase 2

Recruiting

Led By Martha P. Mims, MD, PhD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Patients must have a history of stable molecular response, defined as MR4.5 for ≥24 months, as documented by ≥3 separate tests performed at least three months apart

Patients who are 18 years or older

Must not have

Active liver disease (e.g., chronic active hepatitis, cirrhosis)

Known diagnosis of human immunodeficiency virus (HIV) infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of tki cessation to the date of the event defined or censoring, assessed at 6 months and up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if it's safe to stop taking a tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML) patients who have shown a stable molecular response.

Who is the study for?

This trial is for adults with chronic myeloid leukemia (CML) who have been on TKI therapy for over 3 years and show a stable molecular response. They must have good blood counts, no signs of aggressive leukemia outside the bone marrow, and be expected to live more than a year without treatment. Participants need to understand the study's research nature and consent in writing.

What is being tested?

The study tests if patients with CML can safely stop taking their tyrosine kinase inhibitors (TKIs), which are drugs like Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib. If needed, it also looks at what happens when these drugs are restarted.

What are the potential side effects?

While not directly testing side effects of medications since this is about stopping them, potential risks include return of leukemia symptoms or loss of disease control. Side effects from restarting TKIs may include nausea, muscle pain, rash or edema.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has been stable for over 2 years, confirmed by 3 tests.

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I am 18 years old or older.

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My leukemia is Philadelphia chromosome or BCR-ABL1 positive.

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I do not have leukemia outside of my bone marrow.

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I have been on TKI medication for more than 36 months.

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I can do most of my daily activities without help.

Exclusion Criteria

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

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I have an ongoing liver condition like hepatitis or cirrhosis.

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I have been diagnosed with HIV.

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I have had or am planning to have a stem cell transplant from a donor.

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My cancer's genetic marker cannot be measured by a common test.

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I haven't stopped my TKI therapy for more than 14 days in a row or 6 weeks in total over the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of tki cessation to the date of the progression defined or censoring, assessed at 6 months and up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of tki cessation to the date of the progression defined or censoring, assessed at 6 months and up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of tki cessation to the date of the progression defined or censoring, assessed at 6 months and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Molecular relapse (MR) free survival

Secondary study objectives

Event free survival (EFS)

Progression-free survival (PFS)

ddPCR of BCR-ABL1 values affecting MR free survival

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: All Subjects Enrolled (stop taking TKI)Experimental Treatment2 Interventions

Patients with a diagnosis of Philadelphia chromosome- or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR), prior evidence of a quantifiable BCR-ABL1 transcript by RT-PCR, and whom have been taking TKI for \> 36 months with a current status of complete molecular remission (CMR). TKI cessation begins within 7 days of study registration. Patients undergo BCR-ABL1 test every month in 24 months.

0 / 11Eligibility criteria met