Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World Population

Launched by BAYLOR COLLEGE OF MEDICINE · Nov 10, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether it's safe and effective for patients with chronic myeloid leukemia (CML) to stop taking their tyrosine kinase inhibitors (TKIs) if they have been in stable remission for a certain period. The study is looking for adults aged 18 and older who have been diagnosed with CML and have maintained a good response to treatment for at least two years. To qualify, participants must have been on TKI therapy for more than three years and currently show no signs of the disease, as confirmed by recent tests.

If you or a loved one decides to participate, you will be closely monitored after stopping the TKI medication to ensure your health remains stable. It’s important to know that participants must be in good overall health and not have any serious other medical conditions. This study is currently recruiting, and all participants will need to give their written consent to join. This research could lead to new insights about managing CML and help determine if some patients can safely discontinue their medication without risking a relapse.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Patients who are 18 years or older
• • 2. Patients have a diagnosis of Philadelphia chromosome- or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).
• • 3. Prior evidence of a quantifiable BCR-ABL1 transcript by RT-PCR
• • 4. Patients who have been taking TKI for \> 36 months.
• • 5. 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.
• • 6. 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.
• • 7. ECOG performance status \< 2
• 8. 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
• • 9. Patients must not have any signs of extramedullary leukemia
• • 10. Patients must have a life expectancy of more than 12 months in the absence of any intervention
• • 11. All participants must be informed of the investigational nature of this study and must sign and give written informed consent
• • 12. Contraception requirements will be as per routine clinical practice.
• • Exclusion Criteria
• • 1. Patients who are unable or unwilling to give their consent to participate to the study.
• • 2. Previous or planned allogeneic stem cell transplantation
• • 3. Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping Imatinib.
• • 4. Patient has received an investigational agent within last 2 years
• • 5. Atypical BCR-ABL transcript not quantifiable by standard RQ-PCR.
• • 6. 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.
• • 7. Another primary malignant disease, except those that do not currently require treatment (adequately treated conditions, such as excised skin cancer or cervical intra-epithelial neoplasia would not be considered exclusion criteria. If in doubt, please refer to the Principal Investigator).
• • 8. Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study.
• • 9. Active liver disease (e.g., chronic active hepatitis, cirrhosis).
• • 10. Known diagnosis of human immunodeficiency virus (HIV) infection.