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

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.

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.

Sponsors & Collaborators

• University of Chicago

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Emory University

  collaborator OTHER

• Barbara Ann Karmanos Cancer Institute

  collaborator OTHER

• Duke Cancer Institute

  collaborator OTHER

• Fred Hutchinson Cancer Center

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• H. Lee Moffitt Cancer Center and Research Institute

  collaborator OTHER

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Ehab Atallah, MD · Medical College of Wisconsin

• Kathryn Flynn, PhD · Medical College of Wisconsin

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-18

Primary Completion

2021-04-06

Completion

2022-04-06

FDA Drug

Yes

Countries

• United States

Study Locations