CML, CML-CP,MMR,TKIPhase 3NCT02204644
The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML
A Phase 3 study testing Flumatinib 600mg qd and Imatinib 400mg qd in people with CML, CML-CP,MMR,TKI, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia. Randomized,Open Label,Control Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CML, CML-CP,MMR,TKI
- What is being tested?
- Flumatinib 600mg qd and Imatinib 400mg qd
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 2017
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-75 year-old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph + CP-CML) within 6 months of diagnosis
- Adequate organ function
Who cannot join
- received TKIs drug treatment before enrollment
- Central nervous system leukemia
- Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation)
- Cardiac dysfunction
- Previous splenectomy
- History of congenital or acquired bleeding disorders unrelated to CML
Show all 9Show fewer
- Previous malignancy except CML
- Acute or chronic liver or severe kidney disease unrelated to CML
- Pregnant, breastfeeding, child bearing potential but failed to take effective contraception
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
About this study
Official title: Randomized, Multi-center, Open-label Phase III Study of the Efficacy and Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia.
A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.
Randomized,Open Label,Control
- Conditions
- CML, CML-CP,MMR,TKI
- Being tested
- Flumatinib 600mg qd, Imatinib 400mg qd
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flumatinib 600mg qdDrug
Imatinib 400mg qdDrug
| Study group | Role | What they receive |
|---|---|---|
| Flumatinib mesylate tablets | Experimental | Flumatinib mesylate tablets 600mg qd for 12 months Receives: Drug: Flumatinib 600mg qd |
| Imatinib mesylate tablets | Active comparator | Imatinib mesylate tablets 400mg qd for 12months Receives: Drug: Imatinib 400mg qd |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIX-month major molecular response rate
Measured: six months
Secondary outcomes (1)
major molecular response rate
Measured: 3 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CML, CML-CP,MMR,TKIStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204644
- Sponsor's protocol ID
- HS-10096-301
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2014
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang L, Meng L, Liu B, Zhang Y, Zhu H, Cui J, Sun A, Hu Y, Jin J, Jiang H, Zhang X, Li Y, Liu L, Zhang W, Liu X, Gu J, Qiao J, Ouyang G, Liu X, Luo J, Jiang M, Xie X, Li J, Zhao C, Zhang M, Yang T, Wang J. Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase III, Randomized, Open-label, Multi-center FESTnd Study. Clin Cancer Res. 2021 Jan 1;27(1):70-77. doi: 10.1158/1078-0432.CCR-20-1600. Epub 2020 Sep 14.
PubMed 32928796
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multi-center, Open-label Phase III Study of the Efficacy and Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia.
- ClinicalTrials.gov ID
- NCT02204644
- Acronym / sponsor ID
- HS-10096-301
- Conditions
- CML, CML-CP,MMR,TKI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Jul 2014 (estimated)
- 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.
A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.
Randomized,Open Label,Control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flumatinib mesylate tablets | Experimental | Drug: Flumatinib 600mg qdFlumatinib mesylate tablets 600mg qd for 12 months |
| Imatinib mesylate tablets | Active comparator | Drug: Imatinib 400mg qdImatinib mesylate tablets 400mg qd for 12months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 18-75 year-old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph + CP-CML) within 6 months of diagnosis
- Adequate organ function
Key exclusion criteria (9 listed)
- received TKIs drug treatment before enrollment
- Central nervous system leukemia
- Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation)
- Cardiac dysfunction
- Previous splenectomy
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 600mg qd | Drug | Flumatinib mesylate tablets |
| Imatinib 400mg qd | Drug | Imatinib mesylate tablets |
Primary outcome
SIX-month major molecular response rate
Time frame: six months
1 secondary outcome
major molecular response rate
Time frame: 3 months, 9 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Derived from this study: PubMed 32928796Zhang L, Meng L, Liu B, Zhang Y, Zhu H, Cui J, Sun A, Hu Y, Jin J, Jiang H, Zhang X, Li Y, Liu L, Zhang W, Liu X, Gu J, Qiao J, Ouyang G, Liu X, Luo J, Jiang M, Xie X, Li J, Zhao C, Zhang M, Yang T, Wang J. Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase III, Randomized, Open-label, Multi-center FESTnd Study. Clin Cancer Res. 2021 Jan 1;27(1):70-77. doi: 10.1158/1078-0432.CCR-20-1600. Epub 2020 Sep 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flumatinib 600mg qd and Imatinib 400mg qd in people with CML, CML-CP,MMR,TKI, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. 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 4 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: finished, as of the sponsor's last update on 27 Feb 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIX-month major molecular response rate (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02204644, which also lists 1 linked publication.
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 27 Feb 2018.