Chronic Myeloid Leukemia in Chronic PhasePhase 4DESCMLNCT07839988
De-escalation Strategy of Tyrosine Kinase Inhibitors Before Treatment Discontinuation in Patients With Chronic Myeloid Leukemia
A Phase 4 study testing Halve TKIs and Withdrawal TKIs in people with Chronic Myeloid Leukemia in Chronic Phase, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if a 1-year dose-reduction strategy with tyrosine kinase inhibitors (TKIs) - before complete discontinuation - works to improve treatment-free remission in adults with chronic-phase chronic myeloid leukaemia (CML) who have already achieved stable deep molecular response and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Myeloid Leukemia in Chronic Phase
- What is being tested?
- Halve TKIs and Withdrawal TKIs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2026to 31 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Patients in chronic phase, with no history of accelerated phase (AP-CML) or blast phase (BP-CML).
- Treatment with a first-generation TKI for ≥5 years; treatment with a second-generation TKI for ≥3 years; for resistant patients, treatment with an effective TKI for ≥5 years.
- Prior evidence of detectable BCR::ABL1 transcripts. Stable deep molecular response (DMR) for >2 years (MR⁴, BCR::ABL1¹⁵ ≤0.01%), with at least 4 test results meeting the criterion and each test at least 3 months apart.
- Availability of reliable qPCR testing with a sensitivity of at least MR⁴·⁵ (BCR::ABL1¹⁵ ≤0.0032%), and test results available within 2 weeks.
Who cannot join
- Received stem cell transplantation before study entry.
- Presence of diseases associated with immunodeficiency, such as syphilis, hepatitis C, or HIV.
- Concurrent participation in other clinical studies.
- Having another malignant disease, unless the other primary malignancy is currently of no clinical significance or does not require active intervention.
- Major surgery within 4 weeks, or not recovered from a previous surgery.
- Pregnancy, lactation, or women planning to become pregnant.
Show all 10Show fewer
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≥3.
- Inability to comply with protocol procedures or to attend follow-up visits on time.
- Known allergy or contraindication to the study drug (active pharmaceutical ingredient and/or excipients).
- Any other condition that the investigator considers makes the patient unsuitable for enrolment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Na Xu, MD, 86-18620698390, sprenaa@163.com
About this study
Official title: De-escalation Strategy of Tyrosine Kinase Inhibitors Before Treatment Discontinuation in Patients With Chronic Myeloid Leukemia: Dose Reduction Versus Discontinuation - a Multicenter, Prospective, Randomized Controlled Study
The goal of this clinical trial is to learn if a 1-year dose-reduction strategy with tyrosine kinase inhibitors (TKIs) - before complete discontinuation - works to improve treatment-free remission in adults with chronic-phase chronic myeloid leukaemia (CML) who have already achieved stable deep molecular response and are eligible to stop therapy. It will also learn about the safety of this gradual reduction approach.
The main questions it aims to answer are:
Read more
Does the dose-reduction strategy lead to a higher 2-year molecular relapse-free survival rate (maintaining major molecular response, BCR-ABL1 ≤0.1%) compared with immediate TKI discontinuation? What medical problems (adverse events) do participants experience during and after dose reduction, and how do they differ from those in the direct-stop group? Researchers will compare the dose-reduction group (reduced daily TKI for 12 months, then 1-year follow-up) with the direct-discontinuation group (immediate stop, 2-year follow-up) to see whether gradual reduction is superior in preserving molecular remission. In addition, they will compare the changes in T-cell subsets between the two groups to explore immune mechanisms that may influence treatment-free remission.
Participants will:
Be randomly assigned to either dose reduction or immediate discontinuation; Take reduced TKI (or no drug) daily for 1 year, followed by 1-year observation (total 24 months); Visit the clinic every 2 months for the first 6 months, then every 3 months thereafter, for physical exams, blood tests, molecular monitoring (BCR-ABL1 PCR), and ECG; Have T-cell subsets measured by flow cytometry at months 3, 6, 12, and 24; Complete quality-of-life questionnaires (EORTC QLQ-CML24) at baseline and at months 3, 6, 12, and 24; Report all adverse events; if MMR is lost, they must restart full-dose TKI and be monitored monthly until remission is regained;
Read the detailed description
Chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs) have significantly prolonged survival, but long-term medication leads to adverse events, financial burden, and reduced quality of life, creating a strong desire for treatment discontinuation. Chinese CML patients are diagnosed at a younger median age (45-50 years) than Western populations, exposing them to TKIs earlier and making treatment-free remission (TFR) a particularly urgent goal. Current studies show that direct discontinuation after achieving deep molecular response yields a 2-year molecular relapse-free survival rate of approximately 50%, with some patients experiencing "withdrawal syndrome." Recent evidence suggests that TKI dose reduction may lower relapse risk and reduce adverse effects without compromising efficacy. Therefore, investigating whether a tapering strategy before discontinuation is superior to immediate cessation is of great significance for optimising CML management and improving patients' quality of life. This study aims to investigate the difference in 2-year molecular relapse-free survival between Chinese CML patients who undergo gradual TKI dose reduction and those who discontinue TKI immediately after meeting the criteria for treatment-free remission, and to evaluate whether the dose-reduction strategy is superior to immediate discontinuation in improving molecular relapse-free survival.
- Being tested
- Halve TKIs, Withdrawal TKIs
- Keywords
- CML, Tyrosine kinase inhibitors, TFR, De-escalation, Discontinuation, MMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halve TKIsDrug
Participants receive a reduced dose of their current tyrosine kinase inhibitor (TKI) for 12 months. Doses are halved/reduced per protocol: Flumatinib 400/200 mg QD, Imatinib 200 mg QD, Nilotinib 300 mg QD, Dasatinib 50 mg QD, or Olverembatinib 20 mg QD, based on pre-entry therapy. Followed by 12 months of observation without TKI
Withdrawal TKIsDrug
Participants discontinue all tyrosine kinase inhibitor (TKI) therapy immediately after enrollment. No study drug is administered during the 24-month follow-up period. Regular molecular monitoring (BCR-ABL1 qPCR) is performed according to protocol: every 2 months for the first 6 months, and every 3 months thereafter until month 24. Upon confirmed loss of major molecular response (MMR, BCR-ABL1 > 0.1%), TKI must be re-initiated at the original pre-enrollment dose.
| Study group | Role | What they receive |
|---|---|---|
| De-escalation group | Experimental | 12-month reduced-dose TKI (e.g., imatinib 200 mg, nilotinib 300 mg, dasatinib 50 mg, flumatinib 200/400 mg, or olverembatinib 20 mg daily) followed by 1-year observation Receives: Drug: Halve TKIs |
| Discontinuation group | Active comparator | Participants discontinue all tyrosine kinase inhibitor (TKI) therapy immediately after enrollment. No study drug is administered during the 24-month follow-up period. Receives: Drug: Withdrawal TKIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year molecular relapse-free survival
Molecular relapse is defined as loss of major molecular response (MMR; BCR-ABL1 > 0.1%) at a single time point.
Measured: From enrollment until molecular relapse (loss of MMR) or death from any cause, whichever came first, assessed up to 2 years.
Secondary outcomes (2)
Event-Free Survival (EFS)
EFS is defined as the time from enrollment to the first occurrence of confirmed loss of major molecular response (MMR; BCR-ABL1 > 0.1%), progression to advanced phase disease, or death from any cause, whichever occurs first. Participants without an event are censored at the end of follow-up.
Measured: From date of enrollment until the date of first documented confirmed loss of MMR (BCR-ABL1 > 0.1%), progression to advanced phase, or death from any cause, whichever came first, assessed up to 24 months.
Changes in T cell subsets
Changes in T cell subsets at 3 months, 6 months, 12 months and 24 months after enrollment.
Measured: Changes in T cell subsets at 3 months, 6 months, 12 months and 24 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start9 Sep 2026 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid Leukemia in Chronic PhaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839988
- Sponsor's protocol ID
- NFEC-2026-445
- Other IDs
- NF20251031
- Acronym
- DESCML
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Y, Xu N, Yang Y, Liu Z, Xue M, Meng L, He Q, Chen C, Zeng Q, Zhu H, Du X, Zou J, He W, Guo J, Chen S, Yuan G, Wu H, Hong M, Cheng F, Liu B, Zhang Y, Li W. Quality-of-life, mental health, and perspective on TKI dose reduction as a prelude to discontinuation in chronic phase chronic myeloid leukemia. Cancer Med. 2023 Aug;12(16):17239-17252. doi: 10.1002/cam4.6296. Epub 2023 Jul 6.
PubMed 37409506Saussele S, Richter J, Guilhot J, Gruber FX, Hjorth-Hansen H, Almeida A, Janssen JJWM, Mayer J, Koskenvesa P, Panayiotidis P, Olsson-Stromberg U, Martinez-Lopez J, Rousselot P, Vestergaard H, Ehrencrona H, Kairisto V, Machova Polakova K, Muller MC, Mustjoki S, Berger MG, Fabarius A, Hofmann WK, Hochhaus A, Pfirrmann M, Mahon FX; EURO-SKI investigators. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018 Jun;19(6):747-757. doi: 10.1016/S1470-2045(18)30192-X. Epub 2018 May 4.
PubMed 29735299Luo 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 36467815Clark RE, Polydoros F, Apperley JF, Milojkovic D, Rothwell K, Pocock C, Byrne J, de Lavallade H, Osborne W, Robinson L, O'Brien SG, Read L, Foroni L, Copland M. De-escalation of tyrosine kinase inhibitor therapy before complete treatment discontinuation in patients with chronic myeloid leukaemia (DESTINY): a non-randomised, phase 2 trial. Lancet Haematol. 2019 Jul;6(7):e375-e383. doi: 10.1016/S2352-3026(19)30094-8. Epub 2019 Jun 12.
PubMed 31201085
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalation Strategy of Tyrosine Kinase Inhibitors Before Treatment Discontinuation in Patients With Chronic Myeloid Leukemia: Dose Reduction Versus Discontinuation - a Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07839988
- Acronym / sponsor ID
- DESCML / NFEC-2026-445
- Keywords
- CML, Tyrosine kinase inhibitors, TFR, De-escalation, Discontinuation, MMR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 9 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Sep 2026 (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 goal of this clinical trial is to learn if a 1-year dose-reduction strategy with tyrosine kinase inhibitors (TKIs) - before complete discontinuation - works to improve treatment-free remission in adults with chronic-phase chronic myeloid leukaemia (CML) who have already achieved stable deep molecular response and are eligible to stop therapy. It will also learn about the safety of this gradual reduction approach.
The main questions it aims to answer are:
Does the dose-reduction strategy lead to a higher 2-year molecular relapse-free survival rate (maintaining major molecular response, BCR-ABL1 ≤0.1%) compared with immediate TKI discontinuation? What medical problems (adverse events) do participants experience during and after dose reduction, and how do they differ from those in the direct-stop group? Researchers will compare the dose-reduction group (reduced daily TKI for 12 months, then 1-year follow-up) with the direct-discontinuation group (immediate stop, 2-year follow-up) to see whether gradual reduction is superior in preserving molecular remission. In addition, they will compare the changes in T-cell subsets between the two groups to explore immune mechanisms that may influence treatment-free remission.
Participants will:
Be randomly assigned to either dose reduction or immediate discontinuation; Take reduced TKI (or no drug) daily for 1 year, followed by 1-year observation (total 24 months); Visit the clinic every 2 months for the first 6 months, then every 3 months thereafter, for physical exams, blood tests, molecular monitoring (BCR-ABL1 PCR), and ECG; Have T-cell subsets measured by flow cytometry at months 3, 6, 12, and 24; Complete quality-of-life questionnaires (EORTC QLQ-CML24) at baseline and at months 3, 6, 12, and 24; Report all adverse events; if MMR is lost, they must restart full-dose TKI and be monitored monthly until remission is regained;
Detailed description
Chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs) have significantly prolonged survival, but long-term medication leads to adverse events, financial burden, and reduced quality of life, creating a strong desire for treatment discontinuation. Chinese CML patients are diagnosed at a younger median age (45-50 years) than Western populations, exposing them to TKIs earlier and making treatment-free remission (TFR) a particularly urgent goal. Current studies show that direct discontinuation after achieving deep molecular response yields a 2-year molecular relapse-free survival rate of approximately 50%, with some patients experiencing "withdrawal syndrome." Recent evidence suggests that TKI dose reduction may lower relapse risk and reduce adverse effects without compromising efficacy. Therefore, investigating whether a tapering strategy before discontinuation is superior to immediate cessation is of great significance for optimising CML management and improving patients' quality of life. This study aims to investigate the difference in 2-year molecular relapse-free survival between Chinese CML patients who undergo gradual TKI dose reduction and those who discontinue TKI immediately after meeting the criteria for treatment-free remission, and to evaluate whether the dose-reduction strategy is superior to immediate discontinuation in improving molecular relapse-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De-escalation group | Experimental | Drug: Halve TKIs12-month reduced-dose TKI (e.g., imatinib 200 mg, nilotinib 300 mg, dasatinib 50 mg, flumatinib 200/400 mg, or olverembatinib 20 mg daily) followed by 1-year observation |
| Discontinuation group | Active comparator | Drug: Withdrawal TKIsParticipants discontinue all tyrosine kinase inhibitor (TKI) therapy immediately after enrollment. No study drug is administered during the 24-month follow-up period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Patients in chronic phase, with no history of accelerated phase (AP-CML) or blast phase (BP-CML).
- Treatment with a first-generation TKI for ≥5 years; treatment with a second-generation TKI for ≥3 years; for resistant patients, treatment with an effective TKI for ≥5 years.
- Prior evidence of detectable BCR::ABL1 transcripts. Stable deep molecular response (DMR) for >2 years (MR⁴, BCR::ABL1¹⁵ ≤0.01%), with at least 4 test results meeting the criterion and each test at least 3 months apart.
- Availability of reliable qPCR testing with a sensitivity of at least MR⁴·⁵ (BCR::ABL1¹⁵ ≤0.0032%), and test results available within 2 weeks.
Key exclusion criteria (10 listed)
- Received stem cell transplantation before study entry.
- Presence of diseases associated with immunodeficiency, such as syphilis, hepatitis C, or HIV.
- Concurrent participation in other clinical studies.
- Having another malignant disease, unless the other primary malignancy is currently of no clinical significance or does not require active intervention.
- Major surgery within 4 weeks, or not recovered from a previous surgery.
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 |
|---|---|---|
| Halve TKIsParticipants receive a reduced dose of their current tyrosine kinase inhibitor (TKI) for 12 months. Doses are halved/reduced per protocol: Flumatinib 400/200 mg QD, Imatinib 200 mg QD, Nilotinib 300 mg QD, Dasatinib 50 mg QD, or Olverembatinib 20 mg QD, based on pre-entry therapy. Followed by 12 months of observation without TKI | Drug | De-escalation group |
| Withdrawal TKIsParticipants discontinue all tyrosine kinase inhibitor (TKI) therapy immediately after enrollment. No study drug is administered during the 24-month follow-up period. Regular molecular monitoring (BCR-ABL1 qPCR) is performed according to protocol: every 2 months for the first 6 months, and every 3 months thereafter until month 24. Upon confirmed loss of major molecular response (MMR, BCR-ABL1 > 0.1%), TKI must be re-initiated at the original pre-enrollment dose. | Drug | Discontinuation group |
Primary outcome
2-year molecular relapse-free survival
Time frame: From enrollment until molecular relapse (loss of MMR) or death from any cause, whichever came first, assessed up to 2 years.
Molecular relapse is defined as loss of major molecular response (MMR; BCR-ABL1 > 0.1%) at a single time point.
2 secondary outcomes
Event-Free Survival (EFS)
Time frame: From date of enrollment until the date of first documented confirmed loss of MMR (BCR-ABL1 > 0.1%), progression to advanced phase, or death from any cause, whichever came first, assessed up to 24 months.
Changes in T cell subsets
Time frame: Changes in T cell subsets at 3 months, 6 months, 12 months and 24 months after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 37409506Chen Y, Xu N, Yang Y, Liu Z, Xue M, Meng L, He Q, Chen C, Zeng Q, Zhu H, Du X, Zou J, He W, Guo J, Chen S, Yuan G, Wu H, Hong M, Cheng F, Liu B, Zhang Y, Li W. Quality-of-life, mental health, and perspective on TKI dose reduction as a prelude to discontinuation in chronic phase chronic myeloid leukemia. Cancer Med. 2023 Aug;12(16):17239-17252. doi: 10.1002/cam4.6296. Epub 2023 Jul 6.
- Background: PubMed 29735299Saussele S, Richter J, Guilhot J, Gruber FX, Hjorth-Hansen H, Almeida A, Janssen JJWM, Mayer J, Koskenvesa P, Panayiotidis P, Olsson-Stromberg U, Martinez-Lopez J, Rousselot P, Vestergaard H, Ehrencrona H, Kairisto V, Machova Polakova K, Muller MC, Mustjoki S, Berger MG, Fabarius A, Hofmann WK, Hochhaus A, Pfirrmann M, Mahon FX; EURO-SKI investigators. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018 Jun;19(6):747-757. doi: 10.1016/S1470-2045(18)30192-X. Epub 2018 May 4.
- Background: 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.
- Background: PubMed 31201085Clark RE, Polydoros F, Apperley JF, Milojkovic D, Rothwell K, Pocock C, Byrne J, de Lavallade H, Osborne W, Robinson L, O'Brien SG, Read L, Foroni L, Copland M. De-escalation of tyrosine kinase inhibitor therapy before complete treatment discontinuation in patients with chronic myeloid leukaemia (DESTINY): a non-randomised, phase 2 trial. Lancet Haematol. 2019 Jul;6(7):e375-e383. doi: 10.1016/S2352-3026(19)30094-8. Epub 2019 Jun 12.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Halve TKIs and Withdrawal TKIs in people with Chronic Myeloid Leukemia in Chronic Phase, 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 24 Sep 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Na Xu (86-18620698390, sprenaa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year molecular relapse-free survival (time frame: From enrollment until molecular relapse (loss of MMR) or death from any cause, whichever came first, assessed up to 2 years.). 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 NCT07839988, which also lists 4 linked publications.
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 24 Sep 2026.