Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real Wo… (NCT04626024) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World Population
United States17 participantsStarted 2020-12-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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
What they're measuring
1
Molecular relapse (MR) free survival
Timeframe: From date of TKI cessation to the date of MR or censoring, assessed up to 6 months
. 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.
✕. 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).
✕. Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study.