CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 173 enrolled
Drug / intervention
Imatinib (Stopping their TKI) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02269267
NCT02269267Phase 2Completed
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The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)

Medical College of Wisconsin·interventional·Posted Oct 21, 2014·Updated Mar 3, 2023

In Brief

A Phase 2 clinical trial evaluating Imatinib (Stopping their TKI), Dasatinib (Stopping their TKI), and 2 other interventions for Leukemia, Myeloid, Chronic. Completed, enrolled 173 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Chronic
CountriesUnited States
CollaboratorsUniversity of Chicago, University of California, San Francisco, University of Utah, Dana-Farber Cancer Institute, Emory University, Barbara Ann Karmanos Cancer Institute, Duke Cancer Institute, Fred Hutchinson Cancer Center, Memorial Sloan Kettering Cancer Center, Weill Medical College of Cornell University, H. Lee Moffitt Cancer Center and Research Institute

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 21, 2014
Enrollment StartDec 18, 2014
Primary CompletionApr 6, 2021
Study CompletionApr 6, 2022
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 11.7 years ago

Interventions

Imatinib (Stopping their TKI)drug

Patients with CML on treatment with imatinib 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. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.

Dasatinib (Stopping their TKI)drug

Patients with CML on treatment with dasatinib 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. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.

Nilotinib (Stopping their TKI)drug

Patients with CML on treatment with nilotinib 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. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.

Bosutinib (Stopping their TKI)drug

Patients with CML on treatment with 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. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.