Prospective Investigation of Dynamics of ABL Mutations in Imatinib Failed CML Patients Treated With Nilotinib

NCT01562847 | Unknown DMC

• 1 other identifier: CAMN107AKR05T
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are to investigate expression and frequency of ABL point mutations, a major cause of resistance in imatinib failed CML Asian patients and to find causes of Asian-specific resistance to cancer-targeting therapies through a prospective investigation of dynamics of point mutations and expression of new point mutations during nilotinib treatment.

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• To confirm the patterns of resistance including point mutations which are newly expressed during the nilotinib treatment

  5 years

Secondary Outcomes (1)

• To analyze and evaluate the overall survival and disease free survival in the nilotinib treatment according to progression of the disease and types of point mutations

  5 years

Study Arms (1)

Nilotinib

Drug: Nilotinib

Interventions

Nilotinib DRUG

Patients will be treated with 800 mg nilotinib daily.

Also known as: Nilotinib: Tasigna

Nilotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Korean Adult CML patients

You may qualify if:

• Patients with Philadelphia chromosome-positive or BCR-ABL positive CML
• Chronic, Accelerated phase CML patients who show an inappropriate response to the imatinib treatment or failed the treatment according to ELN 2009 RECOMMENDATION
• Patients with ECOG performance status of 0-3
• Patients who consent to the use of study information and study specimen

You may not qualify if:

• Patients with diseases other than CML
• Patients treated with myelosuppressive anticancer therapy other than Hydroxyurea and Angrelide
• Patients who have been treated with second-generation cancer-targeting drug
• Patients who do not consent to the use of study information and study specimen
• Previously documented T315I mutation
• Impaired cardiac function including any of the following: LVEF by echocardiography \< 45% or below the institutional lower range (whichever is greater); complete left bundle branch block; long QT syndrome or family history of; history or presence of significant ventricular or atrial tachyarrhythmias; clinically significant brachycardia (\< 50 bpm); QTcF \> 450 msec at baseline; right bundle branch block plus left anterior hemiblock; bifascicular block; myocardial infarction ≤ 12 months; uncontrolled angina; other clinically significant heart disease (e.g., congestive heart failure)
• Treatment with strong inhibitors of CYP3A4 or medication that are well documented to prolong the QT interval are contraindicated
• Impaired gastrointestinal(GI)function or GI disease that may significantly alter the absorption of the study drug (e.g., ulcerative diseases, uncontrolled nausea, vomitting, diarrhea, malabsorption syndrome, small bowel resection or gastric bypass surgery)
• History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
• Know cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required)
• Patients who previously had a bone marrow or stem cell transplantation
• Pregnant or breast-feeding patients
• Hypersensitivity to nilotinib or any of the excipients
• The capsules contain lactose, and nilotinib is therefore not recommended for patients with rare hereditary problem of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• Novartis: collaborator

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA analysis for mutation and Bcr-Abl gene quantification using mainly peripheral blood

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong-Wook Kim, MD, PhD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: March 26, 2012
• Study Start: July 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

KR (1)