RecruitingPhase 2NCT04626024
Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World Population
Safety And Efficacy Of Tyrosine Kinase Inhibitor Cessation For Chronic Myeloid Leukemia Patients With Stable Molecular Response In A Real World Population
Sponsor
Baylor College of Medicine
Enrollment
100 participants
Start Date
Dec 22, 2020
Study Type
INTERVENTIONAL
Conditions
Summary
This is a single-arm, phase II study to evaluate safety and efficacy of tyrosine kinase inhibitor (TKI) cessation for chronic myeloid leukemia (CML) patients with stable molecular response in a real world population.
Eligibility
Min Age: 18 Years
Inclusion Criteria15
- Patients who are 18 years or older
- Patients have 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
- Patients who have been taking TKI for \> 36 months.
- 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.
- Patient must have a current status of complete molecular remission (CMR), defined as MR4.5 (per section 5.1), within 30 days of signing consent.
- ECOG performance status \< 2
- Patients must have normal marrow function within 30 days of registration, as defined:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 10E9/L
- Hemoglobin ≥ 9.0 g/dL
- Platelets ≥ 100 x 10E9/L
- Patients must not have any signs of extramedullary leukemia
- Patients must have a life expectancy of more than 12 months in the absence of any intervention
- All participants must be informed of the investigational nature of this study and must sign and give written informed consent
- Contraception requirements will be as per routine clinical practice.
Exclusion Criteria9
- Patients who are unable or unwilling to give their consent to participate to the study.
- Previous or planned allogeneic stem cell transplantation
- Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping Imatinib.
- Patient has received an investigational agent within last 2 years
- Atypical BCR-ABL transcript not quantifiable by standard RQ-PCR.
- Patient cannot have had a known interruption of TKI therapy of greater than 14 consecutive days or for a total of 6 weeks in the six months prior to registration.
- Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study.
- Active liver disease (e.g., chronic active hepatitis, cirrhosis).
- Known diagnosis of human immunodeficiency virus (HIV) infection.
Interventions
OTHERImatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Withdrawal
Stop taking TKI medication
DRUGImatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Re-initiation
Re-start TKI medication
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04626024
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