Efficacy and Safety of Nilotinib in CML-CP

NCT03332511 | Completed Phase 4 DMC

• 1 other identifier: 1110-124-383
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

ENESTKorea is a phase 4, multi-institutional, single-arm, open-label study investigating the efficacy and safety of nilotinib at the currently approved dose (300 mg twice daily) and its exposure-outcome relationship, in adult patients diagnosed as Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Outcome Measures

Primary Outcomes (1)

• Cumulative rate of molecular response 4.5 by 24 months

  Cumulative rate of BCR-ABL1 fusion transcripts ≤ 0.0032%, measured by real-time quantitative polymerase chain reaction and standardized to the international scale

  24 months

Secondary Outcomes (6)

• Cumulative rate of molecular response 3 by 24 months

  24 months

• Cumulative rate of molecular response 3 by 12 months

  12 months

• Cumulative rate of molecular response 4 by 24 months

  24 months

• Cumulative rate of molecular response 4 by 12 months

  12 months

• Progression-free survival

  24 months

Study Arms (1)

Investigational arm

EXPERIMENTAL

Oral nilotinib 300mg twice daily with a 12-hour interval

Drug: Nilotinib

Interventions

Nilotinib DRUG

Nilotinib 300mg twice-daily

Also known as: Tasigna

Investigational arm

Eligibility Criteria

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

You may qualify if:

• Aged 19 or older
• Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase

You may not qualify if:

• CML with atypical BCR-ABL1 transcripts (transcripts other than e13a2 or e14a2)
• Eastern Cooperative Oncology Group performance status ≥ 3
• Cardiac abnormality including a corrected QT interval ≥ 480 milliseconds, complete left bundle branch block, permanent pacemaker implantation, congenital long QT syndrome, history of tachyarrhythmia requiring treatment, clinically significant resting bradycardia, history of acute coronary syndrome within 12 months, and decompensated congestive heart failure
• Organ dysfunction defined by total serum bilirubin levels ≥ 1.5 × the upper limit of the normal range (ULN), creatinine ≥ 1.5 × ULN, aspartate or alanine aminotransferase ≥ 2.5 × ULN, amylase or lipase ≥ 1.5 × ULN and alkaline phosphatase ≥ 2.5 × ULN not directly related to the CML
• Uncontrolled hypertension and/or diabetes
• Active and uncontrolled infection
• Major surgery within two weeks or incomplete recovery from the previous surgery
• Congenital or acquired bleeding tendency
• Impaired gastrointestinal absorption
• History of small bowel resection or bypass surgery
• History of acute pancreatitis within 12 months or chronic pancreatitis
• Concomitant administration of strong irreplaceable CYP3A4 inhibitors or inducers, QT-prolonging agents, or coumarin derivatives
• Any other uncontrolled medical conditions that would present substantial safety risks or compromise compliance with the study treatment

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Novartis Pharmaceuticals: collaborator

Related Publications (1)

• Shin J, Koh Y, Yoon SH, Cho JY, Kim DY, Lee KH, Kim HJ, Ahn JS, Kim YK, Park J, Sohn SK, Moon JH, Lee YJ, Yoon S, Lee JO, Cheong JW, Kim KH, Kim SH, Kim HG, Kim H, Nam SH, Do YR, Park SG, Park SK, Bae SH, Song HH, Shin DY, Oh D, Kim MK, Jung CW, Park S, Kim I. A phase 4 study of nilotinib in Korean patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTKorea. Cancer Med. 2018 May;7(5):1814-1823. doi: 10.1002/cam4.1450. Epub 2018 Mar 25.

  PMID: 29577674 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 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

• Inho Kim, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: May 6, 2013
• Primary Completion: October 24, 2016
• Study Completion: October 24, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share