Multicenter, PhaseⅣ, Open Label Trial of Nilotinib in Adult Patients Diagnosed Philadelphia Chromosome Positive(Ph+) Chronic Myeloid Leukemia in CP/AP Intolerant to Dasatinib

NCT02389920 | Unknown Phase 4

• 1 other identifier: 2014-01-112
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Describe the purpose of the study: This study aims to evaluate the improvement of Dasatinib-related adverse events and to evaluate the treatment effect and safety by measuring the genetic response of nilotinib with nilotinib 400mg BID for 12 months in Philadelphia chromosome-positive chronic myeloid leukemia patients intolerant to Dasatinib.

Conditions

Leukemia, Chronic Myeloid

Outcome Measures

Primary Outcomes (1)

• The rate of improvement of Dasatinib-related adverse events

  at 3 months of nilotinib treatment

Study Arms (1)

Nilotinib

EXPERIMENTAL

nilotinib 400mg BID for 12 months

Drug: Nilotinib

Interventions

Nilotinib DRUG

Nilotinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 19 years old
• Performance status (ECOG) of 0, 1, or 2
• Chronic phase or accelerated phase chronic myeloid leukemia being treated for more than two weeks, switch to nilotinib.
• Appropriate target organ function defined as;
• \- Bilirubin \< 1.5 X ULN- Liver function test, AST (SGOT) and ALT (SGPT) \< 2.5 X ULN- Creatinine \< 1.5 X ULN- Serum amylase and lipase ≤ 1.5 X ULN- Alkaline phosphatase ≤ 2.5 X ULN (only if not related to tumor)
• Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to the start of study drug administration.
• Should have laboratory results as follows.
• \- Potassium ≥ LLN- Magnesium ≥ LLN- Phosphorus ≥ LLN
• Voluntary, signed and dated informed consent prior to any study procedures being performed

You may not qualify if:

• Subjects with the T315I mutation
• Mutation known to be associated with low sensitivity to nilotinib(e.g., Y253H, E255K, E255V, F359V),
• Cardiac function abnormalities as follows are found.
• FEVI \< 45% or less than lower limit of normal of each center on ECG
• QT interval cannot be measured on ECG
• Complete right bundle branch block
• Using a ventricular pacemaker
• Congenital long QT syndrome or family history of long QT syndrome
• Past or present clinically significant ventricular or atrial tachycardia
• Clinically significant bradycardia at rest (\< 50 beats/min)
• Regardless of toxicity after Dasatinib intake, QTc \> 480 msec (using the QTcF formula) at baseline ECG. If QTcF \> 480 msec and electrolytes are not within the normal range, it is necessary to correct electrolytes and re-assess the patient's QTc. According to the result of QTc, the investigator makes a decision on the patient's enrollment.
• Myocardial infarction within 12 months prior to the start of the study
• Other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
• Cytopathologically confirmed central nervous system lumbar puncture (spinal tapping is not needed if it is not suspected of association with central nervous system)
• Severe or uncontrolled disease (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection)

Sponsors & Collaborators

• Samsung Medical Center: lead

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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samsung Medical Center

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 17, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 17, 2015

Record last verified: 2015-03