Nilotinib for First-line Newly Diagnosed CML-CP Patients

NCT03942094 | Unknown Phase 3

• 1 other identifier: Nilotinib20190426
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase IIIb, multi-centre, single-arm, open-label, prospective study investigating the efficacy and safety of nilotinib as the first-line treatment for the adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP) in China. Nilotinib 300 mg BID will be provided in this study. The assessment for the primary efficacy endpoint will be performed at 18 months and the rate of patients obtaining MR4.5 will be measured at this time point. Secondary endpoints include the complete hematologic response(CHR) and the rates of major molecular reactions (MMR) by 3, 6, 9,12,18 and 24 months; event free survival (EFS); overall survival (OS).

Conditions

Chronic Myeloid Leukemia, Chronic Phase; Nilotinib

Keywords

Nilotinib

Outcome Measures

Primary Outcomes (1)

• Molecular response (MR) 4.5 at 18 months of nilotinib 300 mg twice a day

  18 months

Secondary Outcomes (5)

• Molecular Response 4.5 at 3, 6, 9, 12, 24 months of nilotinib

  24 months

• Major Molecular Response at 3, 6, 9, 12, 24 months of nilotinib

  24 months

• Rate of CCyR (complete cytogenetic responses: bone marrow Philadelphie positive at 0 % on at least 20 metaphases) at 3, 6, 9, 12, 24 months of nilotinib.

  24 months

• Event-free survival

  24 months

• Overall survival

  24 months

Study Arms (1)

Nilotinib

EXPERIMENTAL

Drug: Nilotinib

Interventions

Nilotinib DRUG

Nilotinib (Tasigna ®), capsules of 150 mg Nilotinib 2 capsules of 150 mg, orally, twice daily

Nilotinib

Eligibility Criteria

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

You may qualify if:

• Male and female patients
• Newly diagnosed CP-CML within 6 months prior to study entry, positive Philadelphia chromosome or positive BCR-ABL (M-bcr transcript)
• Age ≥ 18 years old (no upper age limit given)
• CML-CP defined by primordial cells in peripheral blood or bone marrow \<20%, basophils in peripheral blood \<20%, platelets ≥100 x 109/L(≥100,000/mm3), except for hepatosplenomegaly
• Patient for whom treatment with Imatinib within 2 weeks is expected No other CML treatment except for hydroxyurea and/or anagrelide and/or IFN ECOG score 0 to 2
• Organ function defined by total serum bilirubin levels \< 1.5 × the upper limit of the normal range (ULN), SGOT and SGPT \< 2.5 UNL, creatinine \< 1.5 × ULN, amylase and lipase ≤ 1.5 × ULN and alkaline phosphatase ≤ 2.5 × ULN not directly related to the CML
• Laboratory values defined by potassium ≥ LLN, magnesium ≥ LLN, phosphate ≥ LLN, total calcium (correction for serum albumin) ≥ LLN
• No planned allogeneic stem cell transplantation
• Signed informed consent

You may not qualify if:

• Patients confirmed to have a T315I mutation
• TKIs are not allowed to be treated prior to entering the study, unless the patient has an emergency pending the start of the study, and any dose of commercial imatinib may be used to the patient, but no more than 2 weeks
• Treatment with IFN for more than 3 mouths
• Impaired cardiac function including any of the following:
• Complete left bundle branch block
• Right bundle branch block plus left anterior hemiblock,bifascicular block
• Use of a ventricular-paced pacemaker
• Congenital long QT syndrome
• Clinically significant ventricular or atrial tachyarrhythmias
• Clinically significant resting bradycardia (\<50 beats per minute)
• QTcF \>450 msec on screening ECG.If QTcF \>450 msec and electrolytes are not within normal ranges before nilotinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF criterion
• Myocardial infarction within 12 months prior to starting nilotinib
• Other clinical significant heart disease (e.g. unstable angina,congestive heart failure,uncontrolled hypertension)
• Patients who are confirmed CNS infiltration by cytopathology
• Concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infections)

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Affiliated Hospital of Guangdong Medical University: collaborator
• Huazhong University of Science and Technology Union Shenzhen Hospital: collaborator
• Dongguan People's Hospital: collaborator
• Longgang District People's Hospital of Shenzhen: collaborator

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

RECRUITING

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)