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Nilotinib for First-line Newly Diagnosed CML-CP Patients | Clinical Trials | Clareo Health

UNKNOWNPHASE3

Nilotinib for First-line Newly Diagnosed CML-CP Patients

Efficacy and Safety of Nilotinib as the First-line Treatment for Patients With Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia: a Prospective Study

NCT03942094•Shenzhen Second People's Hospital

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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:
•1. Complete left bundle branch block
•2. Right bundle branch block plus left anterior hemiblock,bifascicular block
•3. Use of a ventricular-paced pacemaker
•4. Congenital long QT syndrome
•5. Clinically significant ventricular or atrial tachyarrhythmias
•6. Clinically significant resting bradycardia (\<50 beats per minute)
+16 more criteria

Locations (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Key Dates

Start Date

June 1, 2019

Primary Completion Date

June 1, 2023

Completion Date

December 1, 2023

Last Updated

March 16, 2022

Enrollment

100

ESTIMATED participants

Conditions

Chronic Myeloid Leukemia, Chronic PhaseNilotinib

Interventions

Nilotinib

DRUG

Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

NCT06119269

Chronic Myeloid Leukemia, Chronic Phase

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COMPLETEDPHASE2

A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase

NCT04126681

Chronic Myeloid Leukemia, Chronic Phase

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COMPLETED

Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Nilotinib for First-line Newly Diagnosed CML-CP Patients

Inclusion Criteria

Exclusion Criteria

Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase

Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib

Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia

Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.

Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia