The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.

Randomized,Open Label,Control

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase II Study of Flumatinib Versus Imatinib to Treat Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

NCT01503502

Myelogenous Leukemia, Chronic

UNKNOWN PHASE2

Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia

NCT02317159

Chronic Myeloid Leukemia

UNKNOWN PHASE4

Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia

NCT04591197

Validity and Safety

UNKNOWN

Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients

NCT01275196

Chronic Myeloid Leukemia

COMPLETED PHASE3

Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)

NCT00514488

Chronic Myeloid Leukemia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

CML, CML-CP,MMR,TKI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Flumatinib mesylate tablets

Flumatinib mesylate tablets 600mg qd for 12 months

Group Type EXPERIMENTAL

Flumatinib 600mg qd

Intervention Type DRUG

Imatinib mesylate tablets

Imatinib mesylate tablets 400mg qd for 12months

Group Type ACTIVE_COMPARATOR

Imatinib 400mg qd

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flumatinib 600mg qd

Intervention Type DRUG

Imatinib 400mg qd

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Men and women aged 18-75 year-old
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
3. Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph + CP-CML) within 6 months of diagnosis
4. Adequate organ function

Exclusion Criteria

1. received TKIs drug treatment before enrollment
2. Central nervous system leukemia
3. Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation)
4. Cardiac dysfunction
5. Previous splenectomy
6. History of congenital or acquired bleeding disorders unrelated to CML
7. Previous malignancy except CML
8. Acute or chronic liver or severe kidney disease unrelated to CML
9. Pregnant, breastfeeding, child bearing potential but failed to take effective contraception

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No