Clinical trial · Interventional
The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
NCT02269267CI-TRIAL-00064433completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Discontinuation of TKI medication
- description
- Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
- interventionNames
- Drug: Imatinib (Stopping their TKI)
- Drug: Dasatinib (Stopping their TKI)
- Drug: Nilotinib (Stopping their TKI)
- Drug: Bosutinib (Stopping their TKI)
Primary outcomes (7)
- measure
- Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
- timeFrame
- 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36 months
- description
- The number of patients who develop molecular recurrence after discontinuing TKIs. This will be reported as the number of new occurrences from the end of the prior time frame.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 or older at time of study entry 2. Willing and able to give informed consent 3. 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 4. Currently taking imatinib, dasatinib, nilotinib or bosutinib 5. Patient has been on TKI therapy for at least 3 years 6. Documented BCR-ABL \<0.01% (\>MR4 i.e. \>4 log reduction) or undetectable BCR-ABL by PCR for at least 2 years according to the patient's local lab 7. Documented BCR-ABL \<0.01% (\>MR4 i.e. \>4 log reduction) or undetectable BCR-ABL at least 3 times prior to screening according to the patient's local lab 8. Two (2) Screening PCRs have been completed and both results are \< 0.01% (\>MR4 i.e \> 4 log reduction) by central lab 9. Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed) 10. Patient has been compliant with therapy per treating physician Exclusion Criteria: 1. Prior hematopoietic stem cell transplantation 2. Poor compliance with taking TKI 3. Unable to comply with lab appointments schedule and PRO assessments 4. Life expectancy less than 36 months 5. Patients who have been resistant to previous TKI therapy are not eligible 6. Pregnant or lactating women
References
Publications (2)
- RESULTAtallah E, Schiffer CA, Weinfurt KP, Zhang MJ, Radich JP, Oehler VG, Pinilla-Ibarz J, Deininger MWN, Lin L, Larson RA, Mauro MJ, Moore JO, Ritchie EK, Shah NP, Silver RT, Wadleigh M, Cortes J, Thompson J, Guhl J, Horowitz MM, Flynn KE. Design and rationale for the life after stopping tyrosine kinase inhibitors (LAST) study, a prospective, single-group longitudinal study in patients with chronic myeloid leukemia. BMC Cancer. 2018 Apr 2;18(1):359. doi: 10.1186/s12885-018-4273-1. PMID 29609532
- RESULTAtallah E, Schiffer CA, Radich JP, Weinfurt KP, Zhang MJ, Pinilla-Ibarz J, Kota V, Larson RA, Moore JO, Mauro MJ, Deininger MWN, Thompson JE, Oehler VG, Wadleigh M, Shah NP, Ritchie EK, Silver RT, Cortes J, Lin L, Visotcky A, Baim A, Harrell J, Helton B, Horowitz M, Flynn KE. Assessment of Outcomes After Stopping Tyrosine Kinase Inhibitors Among Patients With Chronic Myeloid Leukemia: A Nonrandomized Clinical Trial. JAMA Oncol. 2021 Jan 1;7(1):42-50. doi: 10.1001/jamaoncol.2020.5774. PMID 33180106