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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 have a diagnosis of Philadelphia chromosome- or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR)
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

TOKIN Trial 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.Check my eligibility
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.See study design
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.

TOKIN Trial 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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My leukemia is Philadelphia chromosome or BCR-ABL1 positive.
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I have been on TKI medication for more than 36 months.
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I do not have leukemia outside my bone marrow.
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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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My cancer has been stable for over 2 years, confirmed by 3 tests.
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I am in complete molecular remission as defined by MR4.5.
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I can do most of my daily activities without help.
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My blood cell counts are within normal ranges.
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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.
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I am 18 years old or older.

TOKIN Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Molecular relapse (MR) free survival
Secondary outcome measures
Event free survival (EFS)
Progression-free survival (PFS)
ddPCR of BCR-ABL1 values affecting MR free survival

TOKIN 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.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
999 Previous Clinical Trials
6,001,797 Total Patients Enrolled
29 Trials studying Leukemia
1,272 Patients Enrolled for Leukemia
Martha P. Mims, MD, PhDPrincipal InvestigatorBaylor College of Medicine

Media Library

Bosutinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04626024 — Phase 2
Leukemia Research Study Groups: All Subjects Enrolled (stop taking TKI)
Leukemia Clinical Trial 2023: Bosutinib Highlights & Side Effects. Trial Name: NCT04626024 — Phase 2
Bosutinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04626024 — Phase 2

Frequently Asked Questions

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

What adverse effects have been associated with the discontinuation of Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib?

"Considering the Phase 2 status of this drug, Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Withdrawal was deemed a safety score of two due to its limited evidence base."

Answered by AI

Is there an opportunity for volunteers to join this experiment?

"This medical trial, the initiation of which was documented on December 22nd 2020, is currently enrolling patients. Data hosted on clinicaltrials.gov reflects that the study was recently updated in January 25th 2022."

Answered by AI

What is the aggregate quantity of participants engaged in this research?

"Affirmative. Details on clinicaltrials.gov reveal that this medical trial, which went live on December 22th 2020, is currently recruiting patients. 100 individuals are needed to be recruited from 4 distinct healthcare facilities."

Answered by AI

What are Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Withdrawal typically prescribed to treat?

"Refractory acute lymphoblastic leukemia (ALL) is often managed through Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Withdrawal. These drugs have also proven to be beneficial in the treatment of chordomas, blast phase and refractory chronic phase chronic myeloid leukemias."

Answered by AI

How have Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib withdrawal regimens been examined previously?

"Presently, there are 127 ongoing trials researching Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Withdrawal with 26 in their concluding phase. Of these studies, several have been established within Fukuoka city and more broadly distributed across 5727 sites worldwide."

Answered by AI
~33 spots leftby Nov 2025