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Nilotinib for First-line Newly Diagnosed CML-CP Patients

NCT03942094 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-16

No results posted yet for this study

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

Interventions

DRUG

Nilotinib

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

Sponsors & Collaborators

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Affiliated Hospital of Guangdong Medical University

    collaborator OTHER

  • Huazhong University of Science and Technology Union Shenzhen Hospital

    collaborator UNKNOWN

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • Longgang District People's Hospital of Shenzhen

    collaborator OTHER

  • Shenzhen Second People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2023-06-01
Completion
2023-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03942094 on ClinicalTrials.gov