Validity and SafetyNCT04591197
Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia
An observational study of Validity and Safety, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Validity and Safety
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2020to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: New diagnosed CML-CP patients who are more than 18 years old.
Who may be able to join
- 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
Who cannot join
- 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;
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NanfangH
Guangzhou, Guangdong, 510515
xu na, doctor, 18620698390, sprenaa@163.com
About this study
Official title: 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.
- Conditions
- Validity and Safety
What is being measured
The primary outcome is the main question the study is designed to answer.
MMR rates at 12 months
MMR(BCR/ABL(IS)<0.1%) at 12 months after treating
Measured: 12 monts
Secondary outcomes (1)
VEMR rates at 4 weeks
VEMR((BCR-ABL1/ABL1≤ 40% on the International Scale) at 4weeks after treating
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start9 Dec 2020
- Primary completion1 Jan 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validity and SafetyStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xuna, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591197
- Sponsor's protocol ID
- HS-NF-2020
- Status last verified
- Apr 2022
- First submitted
- 15 Oct 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia : A Prospective, Multi-center, Single Arm Study
- ClinicalTrials.gov ID
- NCT04591197
- Acronym / sponsor ID
- HS-NF-2020
- Conditions
- Validity and Safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- New diagnosed CML-CP patients who are more than 18 years old.
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MMR rates at 12 months
Time frame: 12 monts
MMR(BCR/ABL(IS)<0.1%) at 12 months after treating
1 secondary outcome
VEMR rates at 4 weeks
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validity and Safety, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Na Xu, doctor (18620698390, sprenaa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMR rates at 12 months (time frame: 12 monts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.