- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03251352
TKI Discontinuation in CML Patients of China (TFR_china)
March 15, 2022 updated by: Shenzhen Second People's Hospital
Tyrosine Kinase Inhibitor Discontinuation in Adults Patients With Chronic Myeloid Leukemia in China
The primary objective of this study is to describe the maintenance of the molecular remission after tyrosine kinase inhibitor (TKI) disconnection in chronic myeloid leukaemia (CML) patients in China in the real-world clinical practice setting.
This is a post-marketing, non-interventional, single-arm, prospective registry study in adult patients with chronic phase (CP) and accelerated phase (AP) in China.
Patients will be recruited consecutively from the study sites during the enrollment period.
The enrolled patients will be undertaking TKI discontinuation under the conditions of informed consent and frequent monitoring according to the clinical guideline.
Study Overview
Status
Recruiting
Detailed Description
Tyrosine kinase inhibitors (TKIs) are the standard of care for patients with chronic myeloid leukaemia (CML) in chronic phase.
Imatinib, the first ATP competitive TKI, received approval for use based on a dramatic and durable survival benefit.
Other TKIs, the second generation compounds dasatinib, nilotinib and bosutinib and the third generation drug ponatinib, were designed and tested for a greater target-specific potency.
With the development of these effective TKI treatments, CML disease burden can be reduced to minimal levels, and CML patients can have a life expectancy similar to that of the general population.
Although TKI treatment may result in a deep, stable molecular remission, CML treatment guidelines recommend that patients continue TKI treatment indefinitely.
However, Chronic TKI therapy can cause drug-related adverse reactions and constitute financial difficulties, which can result in decreased adherence to therapy.
Therefore, the concept of a lifelong therapy with TKIs has thus been challenged and treatment-free remission (TFR) strategies will soon integrate clinical practice.TFR can be defined as the ability to maintain molecular remission without taking any TKI therapy.
Studies have demonstrated the feasibility of successful TFR.
In the STIM and TWISTER trials, imatinib discontinuation was proposed providing that patients had achieved deep molecular response for a certain period.
The 2-year probability to maintain such deep molecular response levels without any TKI therapy was 38% in STIM and 47% in TWISTER.
Subsequently, several studies were conducted and confirmed that imatinib-free remission was possible.
Discontinuation of new generation TKIs was also investigated and indicated that dasatinib or nilotinib may promote access to TFR strategies as compared to imatinib.
TFR is on the way to become an important goal in clinical practice, implicating an alternation in CML management guidelines in the near future.
Study Type
Observational
Enrollment (Anticipated)
98
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
-
Shenzhen, Guangdong, China, 518035
- Recruiting
- Shenzhen Second People's Hospital
-
Contact:
- Xin Du, MD
- Phone Number: 8196 075583366388
- Email: duxingz@medmail.com.cn
-
-
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The targeted population is CML patients under TKI treatment in China.
Description
Inclusion Criteria:
- Adults with CML-CP/AP and willingness of TKI discontinuation;
- With ≥ 5 years frontline imatinib, reached MMR (major molecular response) in 2 years, with ≥ 2 years MR (molecular response) 4.5;
- Reached MMR with frontline imatinib, with ≥ 2 years nilotinib, with ≥ 1 year MR4.5;
- Failure with frontline imatinib, reached MMR in 1 year with nilotinib, with ≥ 2 years MR4.5;
- With ≥ 3 years frontline imatinib, reached MMR in 1 year, with ≥ 2 years MR4.5.
Exclusion Criteria:
- Diagnosed with CML-BP before TKI treatment;
- With a TKI discontinuation of over 30 days in the first year;
- With a TKI discontinuation of over 30days on average annually;
- Reduced the dosage of TKI treatment without instructions;
- Transferred to the second-generation TKIs after resistance to imatinib.
- Under the treatment of stem cells transplantation
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
TKI Discontinuation Group
The enrolled patients will be undertaking TKI discontinuation under the conditions of informed consent and frequent monitoring according to the clinical guideline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Molecular Remission Rate
Time Frame: at 12 months
|
The molecular remission rate
|
at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: through study completion, an average of 1 year
|
Incidence of Treatment-free related Adverse Events
|
through study completion, an average of 1 year
|
Recurrence
Time Frame: through study completion, an average of 1 year
|
CML molecular recurrence
|
through study completion, an average of 1 year
|
QoL
Time Frame: through study completion, an average of 1 year
|
EROTC-QLQ-C30 and EROTC-QLQ-CML-24
|
through study completion, an average of 1 year
|
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)
March 1, 2017
Primary Completion (Anticipated)
September 30, 2022
Study Completion (Anticipated)
October 30, 2022
Study Registration Dates
First Submitted
May 7, 2017
First Submitted That Met QC Criteria
August 15, 2017
First Posted (Actual)
August 16, 2017
Study Record Updates
Last Update Posted (Actual)
March 16, 2022
Last Update Submitted That Met QC Criteria
March 15, 2022
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201733572018022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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