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

• Status: Recruiting
• Trial end date: 2023-11-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Dasatinib; Imatinib Mesylate

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; patient cannot have had a known continuous interruption of TKI therapy of greater than 14 days or for a total of 6 weeks in the six months prior to registration.

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), to be done after signed 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. 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).

7. Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study.

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

9. Known diagnosis of human immunodeficiency virus (HIV) infection.