FlumatinibPhase 4NCT04677439
Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure
A Phase 4 study testing Flumatinib in people with Flumatinib and Chronic Myeloid Leukemia, Chronic Phase, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flumatinib, Chronic Myeloid Leukemia, Chronic Phase, Imatinib
- What is being tested?
- Flumatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2023
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Diagnosis of CML-CP with Ph+.
- ECOG performance of 0-2.
- Adequate end organ function defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
- Treatment failure after imatinib at 3 or 6 months with BCR-ABL >10%.
- Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Who cannot join
- Previously documented T315I mutation.
- History of TKI treatments except of imatinib.
- History of undergone major surgery within 4 weeks.
- Patients unwilling or unable to comply with the protocol.
- Pregnant or breast-feeding patients.
- patients with other malignant tumor.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035
About this study
Official title: Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure
The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.
Read the detailed description
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.
- Being tested
- Flumatinib
- Keywords
- Flumatinib, CML-CP with Ph+
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlumatinibDrug
600 mg of Flumatinib orally daily for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Flumatinib | Experimental | Not described Receives: Drug: Flumatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test.
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
Measured: 12 months
Secondary outcomes (4)
Proportion of patients with MR 4.0 at 3, 6, 9, 12 months.
Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.
Measured: 3, 6, 9, 12 months.
Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.
Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.
Measured: 3, 6, 9, 12 months.
Proportion of patients with MMR at 3, 6, 9 months.
Measured: 3, 6, 9 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib.
Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Jan 2021
- Primary completion30 May 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlumatinibStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hainan General Hospital, Sanya Central Hospital, First Affiliated Hospital of Shantou University Medical College, Peking University Shenzhen Hospital, Dongguan People's Hospital
- Responsible party
- Sponsor
- Investigators
- Xin Du, Phd, Principal investigator, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677439
- Sponsor's protocol ID
- Flumatinib20201216
- Status last verified
- Mar 2022
- First submitted
- 16 Dec 2020
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure
- ClinicalTrials.gov ID
- NCT04677439
- Acronym / sponsor ID
- Flumatinib20201216
- Keywords
- Flumatinib, CML-CP with Ph+
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Collaborators
- Hainan General Hospital, Sanya Central Hospital, First Affiliated Hospital of Shantou University Medical College, Peking University Shenzhen Hospital, Dongguan People's Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 21 Dec 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 purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.
Detailed description
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flumatinib | Experimental | Drug: Flumatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Diagnosis of CML-CP with Ph+.
- ECOG performance of 0-2.
- Adequate end organ function defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
- Treatment failure after imatinib at 3 or 6 months with BCR-ABL >10%.
Key exclusion criteria (6 listed)
- Previously documented T315I mutation.
- History of TKI treatments except of imatinib.
- History of undergone major surgery within 4 weeks.
- Patients unwilling or unable to comply with the protocol.
- Pregnant or breast-feeding patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flumatinib600 mg of Flumatinib orally daily for 24 months | Drug | Flumatinib |
Primary outcome
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test.
Time frame: 12 months
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
4 secondary outcomes
Proportion of patients with MR 4.0 at 3, 6, 9, 12 months.
Time frame: 3, 6, 9, 12 months.
Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.
Time frame: 3, 6, 9, 12 months.
Proportion of patients with MMR at 3, 6, 9 months.
Time frame: 3, 6, 9 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Flumatinib
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A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
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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.
Xin Du, Phd principal investigator
Shenzhen Second People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flumatinib in people with Flumatinib and Chronic Myeloid Leukemia, Chronic Phase, run by Shenzhen Second People's Hospital 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 6 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 16 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xin Du, Phd (075583366388, duxingz@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test. (time frame: 12 months). 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 16 Mar 2022.