Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

NCT ID: NCT00644878

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-03-31

Brief Summary

This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib

Conditions

Chronic Myelogenous Leukemia - Chronic Phase

Study Design

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

Study Groups

Nilotinib

Group Type: EXPERIMENTAL

Nilotinib

Intervention Type: DRUG

Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose.

Interventions

Nilotinib

Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose.

Intervention Type: DRUG

Other Intervention Names

Tasigna; AMN 107

Eligibility Criteria

Inclusion Criteria

• Male or female patients ≥ 18 years of age with a confirmed diagnosis of Ph+ CML-CP and CCyR
• A suboptimal molecular response to imatinib defined as:

• Group 1: Treated with 1 year of imatinib, complete cytogenetic response (CCyR) but no major molecular response (MMR) (Bcr-Abl levels >0.1%IS);
• Group 2: No specific duration of imatinib required, achieved CCyR but has >1 log increase in Bcr-Abl transcript levels
• Adequate end organ function
• Patients must have had an imatinib washout period of at least 3 days and not to exceed 7 days prior to the first dose of nilotinib. Group 1 patients must have been treated with imatinib for at least 1 year. There was no imatinib treatment duration requirement for Group 2 patients.
• For Group 1, patients were eligible for screening if they were treated with an imatinib dose of at least 400mg daily. Dose reduction could have occurred as long as the minimum dose was 300mg daily and the reduction lasted ≤ 28 days. The patient was required to be on 400 mg daily (or a higher dose) of imatinib for at least 6 consecutive months leading up to screening for this study.
• For Group 2 patients, dose reduction while on imatinib could have occurred as long as the minimum dose was 300 mg daily, and the reduction lasted ≤28 days.

Exclusion Criteria

• Prior accelerated phase or blast crisis CML
• Patients achieving prior CCyR on imatinib who lost cytogenetic response prior to entering study
• Previously documented T315I mutations
• Prior therapy with any other tyrosine kinase inhibitor except imatinib
• Patients with contraindications to receiving nilotinib, including concomitant medications

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

USC Norris Cancer Center Jane Anne Nohl

Los Angeles, California, United States

Georgia Health Sciences University Dept. of MCG

Augusta, Georgia, United States

Indiana Blood and Marrow Institute

Beech Grove, Indiana, United States

University of Iowa Hospitals & Clinics Univ of Iowa Hosp & Clinic

Iowa City, Iowa, United States

LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center

New Orleans, Louisiana, United States

St. Agnes Hospital

Baltimore, Maryland, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

South Texas Institute of Cancer

Corpus Christi, Texas, United States

Baylor College of Medicine - Breast Care Dan L Duncan Cancer Ctr

Houston, Texas, United States

Central Utah Clinic Central Utah Clinic (7)

Provo, Utah, United States

Froedert Memorial Lutheran Hospital Dept.ofFroedert Memorial

Milwaukee, Wisconsin, United States

Countries

United States

References

Ailawadhi S, Akard LP, Miller CB, Jillella A, DeAngelo DJ, Ericson SG, Lin F, Warsi G, Radich J. Exploratory study on the impact of switching to nilotinib in 18 patients with chronic myeloid leukemia in chronic phase with suboptimal response to imatinib. Ther Adv Hematol. 2017 Jan;8(1):3-12. doi: 10.1177/2040620716678118. Epub 2016 Nov 24.

Reference Type: DERIVED

PMID: 28042454 (View on PubMed)

Other Identifiers

CAMN107AUS09

Identifier Type: -

Identifier Source: org_study_id