Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML

NCT06665412 | Recruiting

• 1 other identifier: RT51KR-IIT01
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to learn about the efficacy and safety profile when Radotinib dose redution is performed in Ph+ CML subjects. The main efficacy is checked by MMR rate by 12 months from IP treatment.

Conditions

Chronic Phase Ph+ Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• To evaluate MMR rate up to 12months following the treatment of Radotinib

  up to 12months

Interventions

Radotinib Hydrochloride DRUG

200mg BID, every day up to 12months

Eligibility Criteria

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

Study Population

Newly diagnosed, CP-CML patients

You may qualify if:

• Male or female patients aged 19 years old or older
• Patients with confirmed diagnosis of chronic phase CML within last 8weeks(throung chromosome testing or bone marrow testing)
• Chronic phase CML is defined as follows:
• Blast in peripheral blood and bone marrow \<15%
• The sum of blast and promyelocyte in peripheral blood and bone marrow \<30%
• Basophil in peripheral blood \<20%
• Platelets count ≥ 50 × 109/L (≥ 50,000/mm3) (But, transient prior therapy related thrombocytopenia \[\<50 × 109/L (\< 50,000/mm3)\] is acceptable)
• No extramedullary involvement other than enlargements of liver and spleen
• Patients with positive Philadelphia chromosome and confirmed expression of BCR:ABL1 transcript
• ECOG scale 0, 1 or 2
• Patients who have adequate organ functions as defined below:
• Total bilirubin \< 1.5 × upper limit of normal (ULN)
• SGOT and SGPT \< 2.5× ULN
• Creatinine \< 1.5 × ULN
• Serum amylase and lipase ≤ 1.5 × ULN

You may not qualify if:

• Patients with Philadelphia chromosome negative
• Patients who used Radotinib for 8 days or longer before study entry
• Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells
• Patients who have hypersensitivity to active ingredient or any of the excipients of this investigational product.
• Patients with impaired cardiac function as defined below:
• Patients who cannot have QT intervals measured according to ECG
• Complete left bundle branch block
• Patients with cardiac pacemakers
• Patients with congenital long QT syndrome or the family history of known long QT syndrome
• The mean QTcF \>450msec ECG tests at baseline
• Clinically significant resting bradycardia (\< 50 bpm) History of, or presence of symptomatic ventricular or atrial tachyarrhythmias
• Clinically significant resting bradycardia (\< 50 bpm)
• Medical history of clinically confirmed myocardial or infarctionof unstable angina (within last 12 months)
• Other clinically significant cardiac disease (e.g. congestive heart failure, or uncontrolled hypertension)
• Cytologically confirmed CNS involvement (if asymptomatic, spinal fluid examination is not necessary prior to first treatment)

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (2)

Hallym University Sacred Heart Hosptial

Anyang-si, Gyeonnggi-do, 14068, South Korea

RECRUITING

Keimyung University Daegu Dongsan Hospital

Daegu, 42601, South Korea

NOT YET RECRUITING

MeSH Terms

Interventions

4-methyl-N-(3-(4-methylimidazol-1-yl)-5-trifluoromethylphenyl)-3-(4-pyrazin-2-ylpyrimidin-2-ylamino)benzamide

Study Officials

• Na Yun Kim

  Il-Yang Pharm. Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Na Yun Kim

CONTACT

82-70-7165-7316; nykim@ilyang.co.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)