Phase 2
Completed N=173
The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
Source: ClinicalTrials.gov NCT02269267 ↗Enrolled (actual)
173
Serious AEs
2.9%
Results posted
Mar 2023
Primary outcomePrimary: Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs. — 0; 4; 12; 11 Participants
Summary
This is a non-randomized, prospective, single-group longitudinal study. The purpose of this study is to improve the decision making process used by physicians and patients when they are considering stopping their Tyrosine Kinase Inhibitor (TKI) medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs. |
0; 4; 12; 11; 7; 5 | — |
| PRIMARY Patient-reported Health Status Related to Fatigue of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs) |
52.9 | — |
| PRIMARY Patient-reported Health Status Related to Fatigue of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs) |
50.2 | — |
| PRIMARY Patient-reported Health Status Related to Diarrhea of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs) |
43.6 | — |
| PRIMARY Patient-reported Health Status Related to Diarrhea of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs) |
40.8 | — |
| PRIMARY Patient-reported Health Status Related to Sleep Status of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs) |
49.7 | — |
| PRIMARY Patient-reported Health Status Related to Sleep Status of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs) |
48.3 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 or older at time of study entry
- Willing and able to give informed consent
- Diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR-ABL protein
- Currently taking imatinib, dasatinib, nilotinib or bosutinib
- Patient has been on TKI therapy for at least 3 years
- Documented BCR-ABL MR4 i.e. >4 log reduction) or undetectable BCR-ABL by PCR for at least 2 years according to the patient's local lab
- Documented BCR-ABL MR4 i.e. >4 log reduction) or undetectable BCR-ABL at least 3 times prior to screening according to the patient's local lab
- Two (2) Screening PCRs have been completed and both results are MR4 i.e > 4 log reduction) by central lab
- Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed)
- Patient has been compliant with therapy per treating physician
Exclusion Criteria
- Prior hematopoietic stem cell transplantation
- Poor compliance with taking TKI
- Unable to comply with lab appointments schedule and PRO assessments
- Life expectancy less than 36 months
- Patients who have been resistant to previous TKI therapy are not eligible
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT02269267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.