- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04591197
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:
- Age ≥ 18 years old, both male and female;
- New Diagnosed Chronic Phase Chronic Myeloid Leukemia.
- Within half a year after diagnosis of CML;
- Previous TKIs treatment was less than 2 weeks;
- The pregnant test of female patients was negative (within 7 days before medication before enrollment);
- Informed consent of the patient or his legal representative
Exclusion Criteria:
- T315I mutation is known to exist;
- Rare atypical transcript types that cannot be standardized internationally;
- Received TKI drugs for more than 2 weeks before enrollment;
- Received interferon therapy for more than 3 months before enrollment;
- Received other anti-CML drugs (except hydroxyurea) for more than 2 weeks or surgical treatment (including hematopoietic stem cell transplantation)
- patients who participate in other clinical studies at the same time;
- patients who having had major surgery or not recovered from surgery within 4 weeks;
- patients who having history of malignant tumor
- Woman who is pregnant or nursing
- Eastern Cooperative Oncology Group Physical Performance Status Score (ECOG PS) > 3;
- Patients known to be allergic or contraindicated to the study drug (APIs and/or excipients).
- 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-NF-2020
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.
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