MMR on 12 MonthNCT05341050
A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML
An observational study of MMR on 12 Month, run by xuna at 2 sites in China.
Trial summary
patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years, continue to be treated with halved dose for 12 months, and then stop for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MMR on 12 Month
- What is being tested?
- TKI
- How many people
- 260 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2022to 31 May 2026
- 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: patients who have been diagnosed with CML-CP and are older than 18 years
Who may be able to join
- Male or female over 18 years
- Patients diagnosed as Ph+ (or Ph- but PCR-positive for BCR-ABL) CML-CP
- Patients have received one of the second-generation TKIs (nilotinib, dasatinib) for at least 3 years
- Patients have maintained MMR (BCR/ABL IS<0.1% or more) at least 2 years
- in the past 24 months, at least three times recent molecular reactions have confirmed MMR
- Patients have signed the informed consent
Who cannot join
- patients with the presence or history of T315I mutation
- patients with the presence of rare unquantifiable atypical transcripts
- Patients with comorbid cardiovascular disease or a history of severe cardiovascular disease
- patients have history of accelerated or blast phase, or suspected blast disease
- patients have received allogeneic hematopoietic stem cell transplantation
- patients have severe abnormal liver and kidney function (ALT > upper limit of normal, AST > 3 times normal upper line, glomerular filtration rate < 50%)
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- patients combined with other tumors or a history of other malignancies ECOG score>3
- Two-line abnormality in the patient's blood routine examination
- women is pregnant or nursing
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
NanfangH
Guangzhou, Guangdong, 510515
NanfangH na, doctor, 18620698390, sprenaa@163.com
- Recruiting
NanfangH
Guangzhou, Guangdong
na xu, doctor, 18620698390, sprenaa@163.com
About this study
Official title: This Study is a Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Drug Discontinuation After Dose Reduction in Ph+CML-CP Patients Threated With 2G-TKI.
patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years, continue to be treated with halved dose for 12 months, and then stop for 12 months.
Read the detailed description
1.Patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years.
2。During the TKI reduction phase, the peripheral blood BCR/ABLIS was detected by Q-PCR every two months and continuously monitored for 12 months. In the TFR period, the peripheral blood BCR/ABLIS was detected once a month for the first 6 months; the peripheral blood BCR/ABLIS was detected once every two months for the next 6 months; after that, the peripheral blood BCR/ABLIS was detected once every three months.
3.If the patients detected molecular recurrence (loss of MMR, BCR/ABL IS>0.1%),the original dose of 2G-TKI should be administered
- Conditions
- MMR on 12 Month
- Being tested
- TKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKIDrug
halve dose of 2G-TKI for 12 months and then withdrawal for 12 months
| Study group | Role | What they receive |
|---|---|---|
| patients with Ph+ CML-CP | Not described Receives: Drug: TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMR(BCR/ABL IS<0.1%) on 24 months
Continue to treat patients at half-dose for 12 months, then stop for 12 months
Measured: 24 months
Secondary outcomes (1)
MRFS
Molecular relapse free survival in 24 months
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 posted22 Apr 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MMR on 12 MonthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xuna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xuna, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341050
- Sponsor's protocol ID
- TKIs-cml
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study is a Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Drug Discontinuation After Dose Reduction in Ph+CML-CP Patients Threated With 2G-TKI.
- ClinicalTrials.gov ID
- NCT05341050
- Acronym / sponsor ID
- TKIs-cml
- Conditions
- MMR on 12 Month
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- xunaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 22 Apr 2022 (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.
patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years, continue to be treated with halved dose for 12 months, and then stop for 12 months.
Detailed description
1.Patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years.
2。During the TKI reduction phase, the peripheral blood BCR/ABLIS was detected by Q-PCR every two months and continuously monitored for 12 months. In the TFR period, the peripheral blood BCR/ABLIS was detected once a month for the first 6 months; the peripheral blood BCR/ABLIS was detected once every two months for the next 6 months; after that, the peripheral blood BCR/ABLIS was detected once every three months.
3.If the patients detected molecular recurrence (loss of MMR, BCR/ABL IS>0.1%),the original dose of 2G-TKI should be administered
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Ph+ CML-CP | – | Drug: TKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have been diagnosed with CML-CP and are older than 18 years
Key inclusion criteria (6 listed)
- Male or female over 18 years
- Patients diagnosed as Ph+ (or Ph- but PCR-positive for BCR-ABL) CML-CP
- Patients have received one of the second-generation TKIs (nilotinib, dasatinib) for at least 3 years
- Patients have maintained MMR (BCR/ABL IS<0.1% or more) at least 2 years
- in the past 24 months, at least three times recent molecular reactions have confirmed MMR
Key exclusion criteria (9 listed)
- patients with the presence or history of T315I mutation
- patients with the presence of rare unquantifiable atypical transcripts
- Patients with comorbid cardiovascular disease or a history of severe cardiovascular disease
- patients have history of accelerated or blast phase, or suspected blast disease
- patients have received allogeneic 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TKIhalve dose of 2G-TKI for 12 months and then withdrawal for 12 months | Drug | patients with Ph+ CML-CP |
Primary outcome
MMR(BCR/ABL IS<0.1%) on 24 months
Time frame: 24 months
Continue to treat patients at half-dose for 12 months, then stop for 12 months
1 secondary outcome
MRFS
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 22 Apr 2022.
Related trials for MMR on 12 Month
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MMR on 12 Month, run by xuna at 2 sites 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 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 22 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 2 sites 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 xu na (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(BCR/ABL IS<0.1%) on 24 months (time frame: 24 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 22 Apr 2022.