A Phase 4 interventional study of Halve TKIs and Withdrawal TKIs in Chronic Myeloid Leukemia in Chronic Phase, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 4, Interventional, and Treatment
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Among 49 studies in Leukemia, Myelogenous, Chronic, BCR-ABL Positive with a site in China — 11 open to participants now, 14 under way, 2 of them phase 3. Leukemia, Myelogenous, Chronic, BCR-ABL Positive · China.
Among the 49 studies in Leukemia, Myelogenous, Chronic, BCR-ABL Positive with a site in China, this one is the 11th largest by planned enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2026, is one of 6 in phase 4, reaches primary completion later than 11 of the 13 other live ones, and was the 48th registered.
894 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →11 of the 49 studies in Leukemia, Myelogenous, Chronic, BCR-ABL Positive with a site in China are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in China, United States, Australia and 14 more countries
Ages 1–18
Novartis Pharmaceuticals · Sites in China
Ages 18–99
Shenzhen TargetRx, Inc. · Sites in China
Ages 18+
Peking University People's Hospital · Sites in China
Ages 18+
Novartis Pharmaceuticals · Sites in China, United States, Argentina and 26 more countries
Ages 7–100
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 79 Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies recruiting now, 48 (61%) set no upper age limit and 20 (25%) stop at 75 or younger; 20 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
49 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 11 · Phase 3 9 · Phase 4 6
First in 2005; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 280 is above the median of 44 across 681 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Median enrollment 144 across the 37 interventional studies, 200 across the 11 observational. Of the 21 that completed or were terminated, 10 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 49 have an industry lead sponsor. The 10 most frequent:
Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
Nanfang Hospital, Southern Medical University has 4 studies filed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive — fewer than ten, so there is no comparison to draw.
3 of the studies in Leukemia, Myelogenous, Chronic, BCR-ABL Positive with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06390306Peking University People's HospitalThe Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP | 2026-12-01 |
| NCT05367765Jiangsu Hansoh Pharmaceutical Co., Ltd.A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase | 2027-04-30 |
| NCT04925479Novartis PharmaceuticalsStudy to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia | 2027-09-03 |
Add all 3 to your calendar (.ics) → With an account.
Among the 49 studies in Leukemia, Myelogenous, Chronic, BCR-ABL Positive with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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;
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Halve TKIs
Participants discontinue all tyrosine kinase inhibitor (TKI) therapy immediately after enrollment. No study drug is administered during the 24-month follow-up period.
Drug: Withdrawal TKIs
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
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.
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.
Time frame: From enrollment until molecular relapse (loss of MMR) or death from any cause, whichever came first, assessed up to 2 years.
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.
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
Changes in T cell subsets at 3 months, 6 months, 12 months and 24 months after enrollment.
Time frame: Changes in T cell subsets at 3 months, 6 months, 12 months and 24 months after enrollment.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Jul 2030, 46 months later.
How these figures are worked out, and which studies are left out of them.
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive →
Nanfang Hospital, Southern Medical University →