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

April 9, 2022 updated by: xuna, Nanfang Hospital of Southern Medical University

Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia : A Prospective, Multi-center, Single Arm Study

The overall survival (OS)of Chronic myeloid leukemia (CML) has been significantly improved since the advent of Tyrosine kinase inhibitors (TKIs) .Nevertheless, there still exists a amount of patients who has poor response or intolerance for TKI drugs( Imatinib, dasatinib, nilotinib). Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib,and it aslo has better security when compared to other TKIs(Imatinib, dasatinib, nilotinib).It will be a better chioce for CML patients.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • NanfangH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

New diagnosed CML-CP patients who are more than 18 years old.

Description

Inclusion Criteria:

  1. Age ≥ 18 years old, both male and female;
  2. New Diagnosed Chronic Phase Chronic Myeloid Leukemia.
  3. Within half a year after diagnosis of CML;
  4. Previous TKIs treatment was less than 2 weeks;
  5. The pregnant test of female patients was negative (within 7 days before medication before enrollment);
  6. Informed consent of the patient or his legal representative

Exclusion Criteria:

  1. T315I mutation is known to exist;
  2. Rare atypical transcript types that cannot be standardized internationally;
  3. Received TKI drugs for more than 2 weeks before enrollment;
  4. Received interferon therapy for more than 3 months before enrollment;
  5. Received other anti-CML drugs (except hydroxyurea) for more than 2 weeks or surgical treatment (including hematopoietic stem cell transplantation)
  6. patients who participate in other clinical studies at the same time;
  7. patients who having had major surgery or not recovered from surgery within 4 weeks;
  8. patients who having history of malignant tumor
  9. Woman who is pregnant or nursing
  10. Eastern Cooperative Oncology Group Physical Performance Status Score (ECOG PS) > 3;
  11. Patients known to be allergic or contraindicated to the study drug (APIs and/or excipients).
  12. A clear history of neurological or psychiatric disorders, including epilepsy or dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMR rates at 12 months
Time Frame: 12 monts
MMR(BCR/ABL(IS)<0.1%) at 12 months after treating
12 monts

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VEMR rates at 4 weeks
Time Frame: 4 weeks
VEMR((BCR-ABL1/ABL1≤ 40% on the International Scale) at 4weeks after treating
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 9, 2020

Primary Completion (ANTICIPATED)

January 1, 2024

Study Completion (ANTICIPATED)

December 30, 2024

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (ACTUAL)

October 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Validity and Safety

3
Subscribe