Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia

NCT ID: NCT02709083

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-07-31

Brief Summary

This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess incidence of major molecular response (MMR) at 12 months.

SECONDARY OBJECTIVES:

I. To assess progression free survival (PFS) at 12 and 24 months.

II. To assess accelerated phase (AP) or blast phase (BP) transformation-free survival at 12 and 24 months.

III. To assess incidence of deep MRs (≥ MR⁴) at 12 months and 24 months.

IV. To assess safety.

V. To assess patient reported outcomes (PRO).

TERTIARY OBJECTIVES:

I. To assess prognostic significance of detecting aberrant myeloid or lymphoid markers on diagnostic bone marrow.

II. To assess ability to enroll subjects who maintain deep molecular remissions in tyrosine kinase inhibitors (TKIs) discontinuation trials.

OUTLINE:

Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.

After completion of study treatment, patients are followed up at 2 weeks and then up to 60 months.

Conditions

Chronic Myelogenous Leukemia; Chronic Myeloid Leukemia; Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment-dasatinib, nilotinib, imatinib

Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.

Group Type: EXPERIMENTAL

Dasatinib

Intervention Type: DRUG

Given orally

Imatinib Mesylate

Intervention Type: DRUG

Given orally

Nilotinib

Intervention Type: DRUG

Given orally

Interventions

Dasatinib

Given orally

Intervention Type: DRUG

Imatinib Mesylate

Given orally

Intervention Type: DRUG

Nilotinib

Given orally

Intervention Type: DRUG

Other Intervention Names

BMS-354825; Sprycel; CGP57148B; Gleevec; Glivec; STI-571; AMN 107; Tasigna

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (CP-CML) (by World Health Organization [WHO] definition) (hydroxyurea permitted up to 7 days prior to enrollment)
• Clinically significant gastrointestinal disease, digestive dysfunction, or surgery that would compromise absorption of oral administration of medications
• Able to give written informed consent and comply with all study visits and procedures

Exclusion Criteria

• Chronic myeloid leukemia (CML) in AP or BP
• Unable to receive TKI for insurance reasons (uninsurable)
• Refuse or unable to perform telephone or video conferences with research coordinator
• Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control while on treatment with TKI
• Any medical or psychological condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial, poses any additional risk for the subject, or confounds the assessment of the subject

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

William Blum

Acting Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Blum, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2016-00162

Identifier Type: REGISTRY

Identifier Source: secondary_id

Winship3143-16

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00087045

Identifier Type: -

Identifier Source: org_study_id