MMR on 12 MonthNCT04143087
Withdrawal or Reduction TKIs in CML-CP
An observational study of MMR on 12 Month, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Compare MMR on 12 month treated with half TKIs(including imatinib, dasatinib, and nilotinib) or TKIs withdrawal. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- MMR on 12 Month
- What is being tested?
- withdrawal TKIs or halve TKIs
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2019to 31 Dec 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed CML chronic phase,Age 18-70 years old,gender is not limited
Who may be able to join
- Age 18-70 years old, gender is not limited;
- Diagnosed CML chronic phase and effective TKI(including imatinib, dasatinib, and nilotinib) was continued for more than 5 years
- Q-PCR monitored BCR/ABLIS duration < 0.0032% in the last 18 months
- Informed consent of the patient or his legal representative
Who cannot join
- Patients had history of CML-AP or CML-BC
- CML patients with previous or current ABL kinase mutations
- CML Patients who have received allogeneic hematopoietic stem cell transplantation
- CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy)
- Woman who is pregnant or nursing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NanfangH
Guangzhou, Guangdong, 510515
xu na, doctor, 18620698390, sprenaa@163.com
About this study
Official title: A Multicenter, Open-access Study of CML-CP Patients Treated With Effective TKIs at Least 5 Years and MR4.5(BCR/ABLIS<0.0032%) Maintenance More Than 18 Months Who Treatment With Half TKIs or Discontinue
Compare MMR on 12 month treated with half TKIs(including imatinib, dasatinib, and nilotinib) or TKIs withdrawal.
Read the detailed description
- Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receive effective Tyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 5 years, and patients with BCR/ABLIS continuous negative in the last 18 months were randomly admitted to maintain the original effective TKI by half or stop taking .
- Q-pcr detected BCR/ABLIS in peripheral blood once every month, once every two months after half a year, and continuously monitored for 12 months.
- If the patients detected molecular recurrence (loss of MMR, BCR/ABLIS > 0.1%), the original dose of TKI should be administered again.
- Conditions
- MMR on 12 Month
- Being tested
- withdrawal TKIs or halve TKIs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withdrawal TKIs or halve TKIsDrug
Stop TKIs or treated by half TKIs
| Study group | Role | What they receive |
|---|---|---|
| Withdrawal TKIs | Not described Receives: Drug: withdrawal TKIs or halve TKIs | |
| halve TKIs | Not described Receives: Drug: withdrawal TKIs or halve TKIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMR(BCR/ABL IS<0.01) on 12 moth
Half dose TKIs or discontinue TKIs treatment
Measured: 12 moth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start23 Oct 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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 MMR on 12 MonthStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xuna, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143087
- Sponsor's protocol ID
- TKIs-cml-002
- Status last verified
- Sep 2021
- First submitted
- 26 Oct 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Luo J, Du X, Lou J, Wu J, Ma L, Huang J, Wang L, Tu C, Liu Z, Chen L, Tan Y, Luo D, Liang H, Yin C, Cao R, Zhou X, Liu Q, Liu X, Xu N. De-escalation or discontinuation of tyrosine kinase inhibitor in patients with chronic myeloid leukemia: A multicentral, open-label, prospective trial in China. EJHaem. 2022 Sep 19;3(4):1220-1230. doi: 10.1002/jha2.550. eCollection 2022 Nov.
PubMed 36467815
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-access Study of CML-CP Patients Treated With Effective TKIs at Least 5 Years and MR4.5(BCR/ABLIS<0.0032%) Maintenance More Than 18 Months Who Treatment With Half TKIs or Discontinue
- ClinicalTrials.gov ID
- NCT04143087
- Acronym / sponsor ID
- TKIs-cml-002
- Conditions
- MMR on 12 Month
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Oct 2019 (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.
Compare MMR on 12 month treated with half TKIs(including imatinib, dasatinib, and nilotinib) or TKIs withdrawal.
Detailed description
- Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receive effective Tyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 5 years, and patients with BCR/ABLIS continuous negative in the last 18 months were randomly admitted to maintain the original effective TKI by half or stop taking .
- Q-pcr detected BCR/ABLIS in peripheral blood once every month, once every two months after half a year, and continuously monitored for 12 months.
- If the patients detected molecular recurrence (loss of MMR, BCR/ABLIS > 0.1%), the original dose of TKI should be administered again.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Withdrawal TKIs | – | Drug: withdrawal TKIs or halve TKIs |
| halve TKIs | – | Drug: withdrawal TKIs or halve TKIs |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed CML chronic phase,Age 18-70 years old,gender is not limited
Key inclusion criteria (4 listed)
- Age 18-70 years old, gender is not limited;
- Diagnosed CML chronic phase and effective TKI(including imatinib, dasatinib, and nilotinib) was continued for more than 5 years
- Q-PCR monitored BCR/ABLIS duration < 0.0032% in the last 18 months
- Informed consent of the patient or his legal representative
Key exclusion criteria (5 listed)
- Patients had history of CML-AP or CML-BC
- CML patients with previous or current ABL kinase mutations
- CML Patients who have received allogeneic hematopoietic stem cell transplantation
- CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy)
- Woman who is pregnant or nursing
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 |
|---|---|---|
| withdrawal TKIs or halve TKIsStop TKIs or treated by half TKIs | Drug | Withdrawal TKIs, halve TKIs |
Primary outcome
MMR(BCR/ABL IS<0.01) on 12 moth
Time frame: 12 moth
Half dose TKIs or discontinue TKIs treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 36467815Luo J, Du X, Lou J, Wu J, Ma L, Huang J, Wang L, Tu C, Liu Z, Chen L, Tan Y, Luo D, Liang H, Yin C, Cao R, Zhou X, Liu Q, Liu X, Xu N. De-escalation or discontinuation of tyrosine kinase inhibitor in patients with chronic myeloid leukemia: A multicentral, open-label, prospective trial in China. EJHaem. 2022 Sep 19;3(4):1220-1230. doi: 10.1002/jha2.550. eCollection 2022 Nov.
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.
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 MMR on 12 Month, run by Nanfang Hospital, Southern Medical 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 4 inclusion and 5 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 5 Sep 2021. 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 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<0.01) on 12 moth (time frame: 12 moth). 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 NCT04143087, 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 5 Sep 2021.