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TKI Cessation for Chronic Myeloid Leukemia (TOKIN Trial)
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.
TOKIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTOKIN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TOKIN Trial Design
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Who is running the clinical trial?
Media Library
- I have an ongoing liver condition like hepatitis or cirrhosis.I have been diagnosed with HIV.My cancer has been stable for over 2 years, confirmed by 3 tests.My leukemia is Philadelphia chromosome or BCR-ABL1 positive.I have been on TKI medication for more than 36 months.I do not have leukemia outside my bone marrow.I am 18 years old or older.My leukemia is Philadelphia chromosome or BCR-ABL1 positive.I do not have leukemia outside of my bone marrow.My cancer has been stable for over 2 years, confirmed by 3 tests.I am in complete molecular remission as defined by MR4.5.I can do most of my daily activities without help.My blood cell counts are within normal ranges.I have had or am planning to have a stem cell transplant from a donor.I have conditions or treatments that increase my risk of cancer returning after stopping Imatinib.My cancer's genetic marker cannot be measured by a common test.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.I have another cancer type but it doesn't need treatment right now.I have been on TKI medication for more than 36 months.My cancer is in complete molecular remission.I can do most of my daily activities without help.I am 18 years old or older.
- Group 1: All Subjects Enrolled (stop taking TKI)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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