The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)

PHASE2CompletedINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

December 18, 2014

Primary Completion Date

April 6, 2021

Study Completion Date

April 6, 2022

Conditions
Leukemia, Myeloid, Chronic
Interventions
DRUG

Imatinib (Stopping their TKI)

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.

DRUG

Dasatinib (Stopping their TKI)

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.

DRUG

Nilotinib (Stopping their TKI)

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.

DRUG

Bosutinib (Stopping their TKI)

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.

Trial Locations (16)

10021

Weill Medical College of Cornell University, New York

10065

Memorial Sloan Kettering Cancer Center, New York

14263

Roswell Park Cancer Institute, Buffalo

27710

Duke University Medical Center, Durham

30322

Winship Cancer Institute of Emory University, Atlanta

33612

Moffit Cancer Center, Tampa

48201

Karmanos Cancer Institute of Wayne State University, Detroit

53226

Froedtert Hospital & Medical College of Wisconsin, Milwaukee

60451

The University of Chicago Medicine Comprehensive Cancer Center at Silver Cross, New Lenox

60637

The University of Chicago, Chicago

77054

MD Anderson Cancer Center, Houston

94143

Helen Diller Family Comprehensive Cancer Center University of California, San Francisco

02215

Beth Israel Deaconess Medical Center (Satellite site of Dana Farber), Boston

Dana Farber Cancer Institute, Boston

84132-2408

University of Utah Huntsman Cancer Institute, Salt Lake City

98109-1024

Fred Hutchinson Cancer Research Center, Seattle

All Listed Sponsors
collaborator

University of Chicago

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

University of Utah

OTHER

collaborator

Dana-Farber Cancer Institute

OTHER

collaborator

Emory University

OTHER

collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

collaborator

Duke Cancer Institute

OTHER

collaborator

Fred Hutchinson Cancer Center

OTHER

collaborator

Memorial Sloan Kettering Cancer Center

OTHER

collaborator

Weill Medical College of Cornell University

OTHER

collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

lead

Medical College of Wisconsin

OTHER

NCT02269267 - The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study) | Biotech Hunter | Biotech Hunter