CML, Chronic Phase; TKINCT04739826
Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
An observational study of CML, Chronic Phase; TKI, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The ultimate goal of CML treatment is to improve survival, including overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and treatment-free remission (TFR). TFR is a new therapeutic goal for chronic myeloid leukemia in chronic phase (CML-CP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CML, Chronic Phase; TKI
- What is being tested?
- Flumatinib Mesylate and Nilotinib Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 491 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2020to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed chronic-phase CML patients (CMP-CP) treated with flumatinib or Nilotinib
Who may be able to join
- Male or female patients ≥18 years of age;
- CML-CP patients diagnosed with CML within half a year；Patients who have been using second-generation TKI nilotinib or flumatinib for first-line treatment in clinical practice, but the history of continuous treatment does not exceed 3 months；3.patients are allowed to receive hydroxyurea treatment before first-line treatment with nilotinib or flumartinib; patients treated with interferon for no more than 3 months and other TKIs for no more than 2 weeks;
- 4.Patients who must sign informed consent before screening
Who cannot join
- T315I mutation ; Y253F/H, E255K/V, F359C/V/I mutations in the nilotinib group;
- Entry into another therapeutic clinical trial;
- Concomitant diseases that, according to the investigator's judgment, pose a serious risk to the patient's safety or completion of the study;
- History of neurological or psychiatric disorders, including epilepsy or dementia;
- Major surgery within 4 weeks prior to Day 1 of study;
- Patients with another primary malignancy,unless the other primary malignancy is currently stable or does not need active intervention;
Show all 9Show fewer
- Women of reproductive age or men who are unable to use adequate methods of contraception, including women who are pregnant or breastfeeding;
- ECOG≥3;
- Patients who are unable to compliance with study or follow-up procedures;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, 215000
Suning Chen, 13814881746, chensuning@sina.com
About this study
Official title: Evaluating Efficacy and Safety of Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia(CML-CP) : A Multicenter, Open-lable, Real World Study
The ultimate goal of CML treatment is to improve survival, including overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and treatment-free remission (TFR). TFR is a new therapeutic goal for chronic myeloid leukemia in chronic phase (CML-CP). In ENESTnd and DASISION trials, both nilotinib and dasatinib achieved DMR more effectively than imatinib. In the guidelines for diagnosis and treatment of chronic myeloid leukemia in China (2020 edition), flumatinib has been recommended as an appropriate first-line treatment for newly diagnosed chronic phase chronic myeloid leukemia (CML-CP) patients. There is no doubt that the second-generation TKIs show great advantages in deep molecular response, which further increases the possibility of achieving treatment-free remission. However, there is no direct comparative study to determine which TKI is better for de novo CML-CP. Thus, we conducted a multi-center, open-lable and real world study to compare the efficacy and safety between flumatinib and nilotinib.
- Conditions
- CML, Chronic Phase; TKI
- Being tested
- Flumatinib Mesylate, Nilotinib Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flumatinib MesylateDrug
Flumatinib mesylate tablets 600mg qd
Nilotinib PillDrug
Nilotinib Capsules 300mg bid
| Study group | Role | What they receive |
|---|---|---|
| flumatinib | flumatinib 600mg QD, fasting administration Receives: Drug: Flumatinib Mesylate; Drug: Nilotinib Pill | |
| nilotinib | nilotinib 300mg BID, fasting administration Receives: Drug: Flumatinib Mesylate; Drug: Nilotinib Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major molecular response rate at 12 months
Major molecular response is defined as ≤ 0.1% BCR-ABL/ABL% by international scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start25 Sep 2020
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CML, Chronic Phase; TKIStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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
- 491 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739826
- Sponsor's protocol ID
- HS-2020-07SZ
- Status last verified
- Jul 2023
- First submitted
- 1 Feb 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Efficacy and Safety of Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia(CML-CP) : A Multicenter, Open-lable, Real World Study
- ClinicalTrials.gov ID
- NCT04739826
- Acronym / sponsor ID
- HS-2020-07SZ
- Conditions
- CML, Chronic Phase; TKI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 491 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Feb 2021 (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 ultimate goal of CML treatment is to improve survival, including overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and treatment-free remission (TFR). TFR is a new therapeutic goal for chronic myeloid leukemia in chronic phase (CML-CP). In ENESTnd and DASISION trials, both nilotinib and dasatinib achieved DMR more effectively than imatinib. In the guidelines for diagnosis and treatment of chronic myeloid leukemia in China (2020 edition), flumatinib has been recommended as an appropriate first-line treatment for newly diagnosed chronic phase chronic myeloid leukemia (CML-CP) patients. There is no doubt that the second-generation TKIs show great advantages in deep molecular response, which further increases the possibility of achieving treatment-free remission. However, there is no direct comparative study to determine which TKI is better for de novo CML-CP. Thus, we conducted a multi-center, open-lable and real world study to compare the efficacy and safety between flumatinib and nilotinib.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flumatinib | – | Drug: Flumatinib Mesylate, Drug: Nilotinib Pillflumatinib 600mg QD, fasting administration |
| nilotinib | – | Drug: Flumatinib Mesylate, Drug: Nilotinib Pillnilotinib 300mg BID, fasting administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed chronic-phase CML patients (CMP-CP) treated with flumatinib or Nilotinib
Key inclusion criteria (3 listed)
- Male or female patients ≥18 years of age;
- CML-CP patients diagnosed with CML within half a year；Patients who have been using second-generation TKI nilotinib or flumatinib for first-line treatment in clinical practice, but the history of continuous treatment does not exceed 3 months；3.patients are allowed to receive hydroxyurea treatment before first-line treatment with nilotinib or flumartinib; patients treated with interferon for no more than 3 months and other TKIs for no more than 2 weeks;
- 4.Patients who must sign informed consent before screening
Key exclusion criteria (9 listed)
- T315I mutation ; Y253F/H, E255K/V, F359C/V/I mutations in the nilotinib group;
- Entry into another therapeutic clinical trial;
- Concomitant diseases that, according to the investigator's judgment, pose a serious risk to the patient's safety or completion of the study;
- History of neurological or psychiatric disorders, including epilepsy or dementia;
- Major surgery within 4 weeks prior to Day 1 of study;
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 |
|---|---|---|
| Flumatinib MesylateFlumatinib mesylate tablets 600mg qd | Drug | flumatinib, nilotinib |
| Nilotinib PillNilotinib Capsules 300mg bid | Drug | flumatinib, nilotinib |
Primary outcome
Major molecular response rate at 12 months
Time frame: 12 months
Major molecular response is defined as ≤ 0.1% BCR-ABL/ABL% by international scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
Related trials for CML, Chronic Phase; TKI
Not yet recruitingPhase 3
A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs
Chronic Myeloid Leukemia (CML), Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
RecruitingPhase 1
TGRX-678 US Phase I for Chronic Myelogenous Leukemia Patients
Chronic Myelogenous Leukemia
RecruitingPhase 2
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive
Active, not recruitingPhase 3
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
Active, not recruitingPhase 3
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
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 CML, Chronic Phase; TKI, run by The First Affiliated Hospital of Soochow 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 3 inclusion and 9 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 3 Nov 2023. 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 Suning Chen (13814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major molecular response rate at 12 months (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 3 Nov 2023.