Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)Phase 2NCT06958705
Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy
A Phase 2 study testing Venetoclax combined with Ibrutinib, Venetoclax combined with Zanubrutinib and Venetoclax combined with Acalabrutinib in people with Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is an open-label, multicenter, phase 2, non-randomized study aiming to study the efficacy and safety of fixed-duration venetoclax consolidation in CLL patients who are on BTK inhibitor monotherapy. Patients who are on BTK inhibitor monotherapy for ≥ 6 months and still responsive are included. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
- What is being tested?
- Venetoclax combined with Ibrutinib, Venetoclax combined with Zanubrutinib and Venetoclax combined with Acalabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Feb 2028
- Phase
- Phase 2
- 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
- 1. Age: 18-80 years-old.
- 2. Patients must have a diagnosis of CLL/SLL.
- 3. Detectable MRD by flow cytometry (10^-4 sensitivity) in the peripheral blood.
- 4. Patients who are on BTK inhibitor monotherapy for more than 6 months. This study includes patients who are taking one of the following BTK inhibitors: ibrutinib, zanubrutinib, orelabrutinib, and acalabrutinib.
- 5. Patients need to have a response of at least PR (CR/PR) to BTK inhibitor monotherapy.
- 6. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
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- 7. Patients must have adequate renal and hepatic function:
- Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for patients with Gilbert's disease;
- Serum creatinine clearance of ≥ 50 ml/min (calculated or measured);
- ALT and AST ≤ 3.0 × ULN, unless clearly due to disease involvement.
- 8. Adequate bone marrow function:
- Platelet count of greater than 50,000/µl, with no platelet transfusion in prior 2 weeks;
- ANC ≥ 1000/µl in the absence of growth factor support unless due to compromised bone marrow production from CLL, indicated by ≥ 80% CLL in marrow;
- Hemoglobin ≥ 8g/dL.
- 9. Adequate cardiac function, as assessed by:
- Absence of uncontrolled cardiac arrhythmia;
- Echocardiogram demonstrating LVEF ≥ 35%;
- NYHA functional class ≤ 2.
- 10. Ability to provide informed consent and adhere to the required follow-up.
Who cannot join
- 1. Richter transformation.
- 2. Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- 3. Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks prior to the first dose of the study drug.
- 4. Grade 3 or 4 hemorrhage within the past 3 weeks.
- 5. Uncontrolled active infections (viral, bacterial, and fungal).
- 6. Females who are pregnant or lactating.
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- 7. Known HIV positive.
- 8. Active hepatitis B infection (defined as the presence of detectable HBV DNA or HBe antigen). Patients who are HBsAg positive or HBcAb positive are eligible, provided HBV DNA is negative. These patients must have monthly monitoring of HBV DNA for the duration of the study.
- 9. Active hepatitis C, defined by the detection of hepatitis C RNA in plasma by PCR.
- 10. Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy > 20 mg prednisone daily or equivalent, within 7 days of starting venetoclax.
- 11. Received other therapeutic agents for CLL/SLL during BTK inhibitor treatment prior to enrollment.
- 12. Concurrent use of warfarin or equivalent vitamin K inhibitor or other oral anticoagulant treatment.
- 13. Received strong CYP3A inhibitors or strong CYP3A inducers within 7 days of starting venetoclax.
- 14. Consuming grapefruit, grapefruit products, Seville oranges, or star fruit within 7 days of starting venetoclax.
- 15. Prior treatment with venetoclax or other Bcl-2 inhibitor.
- 16. Malabsorption syndrome or other condition that precludes enteral route of administration.
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, 1 recruiting
- Recruiting
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Jianyong Li, PhD, MD, 86-13951877733, lijianyonglm@126.com
Huayuan Zhu, PhD, MD, 86-13813810650, huayuan.zhu@hotmail.com
About this study
Official title: Study of the Efficacy and Safety of Venetoclax as Consolidation to Achieve Fix-Duration Treatment in CLL Patients Treated With BTK Inhibitor Monotherapy
This is an open-label, multicenter, phase 2, non-randomized study aiming to study the efficacy and safety of fixed-duration venetoclax consolidation in CLL patients who are on BTK inhibitor monotherapy. Patients who are on BTK inhibitor monotherapy for ≥ 6 months and still responsive are included. The study includes patients who are treatment-naive before taking BTK inhibitors. Patients will be treated with the BTK inhibitor plus full-dose venetoclax for 12 cycles after a standard 5-week dose ramp-up. Peripheral blood and bone marrow MRD status will be evaluated during and after the treatment. After the completion of combination therapy, patients will stop both BTK inhibitor and venetoclax and be followed.
- Being tested
- Venetoclax combined with Ibrutinib, Venetoclax combined with Zanubrutinib, Venetoclax combined with Acalabrutinib, Venetoclax combined with Orelabrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venetoclax combined with IbrutinibDrug
All Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using ibrutinib. After the completion of combination therapy, patients will stop both the ibrutinib and venetoclax then be followed.
Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and ibrutinib will continue for an additional 12 cycles. Venetoclax and ibrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first.
Ibrutinib is intended to be admistratered orally 420mg once daily.
Venetoclax combined with ZanubrutinibDrug
All Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using zanubrutinib. After the completion of combination therapy, patients will stop both the zanubrutinib and venetoclax then be followed.
Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and zanubrutinib will continue for an additional 12 cycles. Venetoclax and zanubrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first.
Zanubrutinib is intended to be admistratered orally 160mg twice daily.
Venetoclax combined with AcalabrutinibDrug
All Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using acalabrutinib. After the completion of combination therapy, patients will stop both the acalabrutinib and venetoclax then be followed.
Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and acalabrutinib will continue for an additional 12 cycles. Venetoclax and acalabrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first.
Acalabrutinib is intended to be admistratered orally 100mg twice daily.
Venetoclax combined with OrelabrutinibDrug
All Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using orelabrutinib. After the completion of combination therapy, patients will stop both the orelabrutinib and venetoclax then be followed.
Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and orelabrutinib will continue for an additional 12 cycles. Venetoclax and orelabrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first.
Orelabrutinib is intended to be admistratered orally 150mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| CLL/SLL patients on ibrutinib monotherapy for ≥ 6 months | Experimental | Not described Receives: Drug: Venetoclax combined with Ibrutinib |
| CLL/SLL patients on zanubrutinib monotherapy for ≥ 6 months | Experimental | Not described Receives: Drug: Venetoclax combined with Zanubrutinib |
| CLL/SLL patients on acalabrutinib monotherapy for ≥ 6 months | Experimental | Not described Receives: Drug: Venetoclax combined with Acalabrutinib |
| CLL/SLL patients on orelabrutinib monotherapy for ≥ 6 months | Experimental | Not described Receives: Drug: Venetoclax combined with Orelabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of BM-uMRD after completion of combination therapy (Day 1 of Cycle 16)
Rate of BM-uMRD is defined by negative MRD in the bone marrow by flow cytometry at a sensitivity of 10^-4. The Clopper Pearson method is used to estimate the 95% two-sided confidence interval (CI) of the rate of BM-uMRD.
Measured: On Day 1 of Cycle 16 (each cycle is 28 days)
Secondary outcomes (6)
Rate of undetected peripheral blood MRD by flow cytometry
Rate of undetected peripheral blood MRD is defined by negative MRD in the peripheral blood by flow cytometry at a sensitivity of 10^-4.
Measured: On screening, Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 16, Day 1 of Cycle 20, Day 1 of Cycle 24, Day 1 of Cycle 28 and Day 1 of Cycle 34 (each cycle is 28 days)
Rate of complete response (CR)
CR is defined by the 2018 IWCLL criteria. Enhanced contrast CT combined with bone marrow examination will be performed to determine if a patient achieve CR.
Measured: On Day 1 of Cycle 7, Day 1 of Cycle 16, Day 1 of Cycle 22, and Day 1 of Cycle 28 (each cycle is 28 days)
Progression-free survival (PFS)
PFS is defined as the time from the first dose of venetoclax to progression, or death due to any cause, whichever occurs first. For subjects without progression, relapse, or death at the time of analysis, EFS will be censored at the last assessment date.
Measured: From the first dose of venetoclax until the date of progression or date of death from any cause, whichever came first, assessed up to 112 months
Overall survival (OS)
OS is defined as the time from the first dose of venetoclax to death due to any cause. Subjects who remain alive at the time of analysis will be censored at the last known alive date of the subject.
Measured: From the first dose of venetoclax until the date of death from any cause, assessed up to 112 months
Time to next treatment (TTNT)
TTNT is defined as the time from the first dose of venetoclax to the next CLL-directed therapies.
Measured: From the first dose of venetoclax to the next CLL-directed therapies due to progression, assessed up to 112 months
Adverse Events
All treatment-emergent AEs will be included in the analysis. For each AE, the number and percentage of subjects who experience at least one occurrence of the given event will be summarized. The number and percent of subjects with TEAEs will be summarized according to intensity (CTCAE, v5) or IWCLL for hematologic toxicity, and drug relationship, as well as categorized by system organ class and preferred term. Summaries, listings, datasets, or subject narratives may be provided, as appropriate, for those subjects who die, who discontinue treatment due to an AE, or who experience a severe AE or a SAE.
Measured: From screening to 30 days after the end of cycle 12 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be treated with the BTK inhibitor plus full-dose venetoclax for 12 cycles after a standard 5-week dose ramp-up. Peripheral blood and bone marrow MRD status will be evaluated during and after the treatment. After the completion of combination therapy, patients will stop both BTK inhibitor and venetoclax and be followed.
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958705
- Sponsor's protocol ID
- 2024-SR-1147
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy and Safety of Venetoclax as Consolidation to Achieve Fix-Duration Treatment in CLL Patients Treated With BTK Inhibitor Monotherapy
- ClinicalTrials.gov ID
- NCT06958705
- Acronym / sponsor ID
- 2024-SR-1147
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 6 May 2025 (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.
This is an open-label, multicenter, phase 2, non-randomized study aiming to study the efficacy and safety of fixed-duration venetoclax consolidation in CLL patients who are on BTK inhibitor monotherapy. Patients who are on BTK inhibitor monotherapy for ≥ 6 months and still responsive are included. The study includes patients who are treatment-naive before taking BTK inhibitors. Patients will be treated with the BTK inhibitor plus full-dose venetoclax for 12 cycles after a standard 5-week dose ramp-up. Peripheral blood and bone marrow MRD status will be evaluated during and after the treatment. After the completion of combination therapy, patients will stop both BTK inhibitor and venetoclax and be followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients will be treated with the BTK inhibitor plus full-dose venetoclax for 12 cycles after a standard 5-week dose ramp-up. Peripheral blood and bone marrow MRD status will be evaluated during and after the treatment. After the completion of combination therapy, patients will stop both BTK inhibitor and venetoclax and be followed.
| Arm | Type | Receives |
|---|---|---|
| CLL/SLL patients on ibrutinib monotherapy for ≥ 6 months | Experimental | Drug: Venetoclax combined with Ibrutinib |
| CLL/SLL patients on zanubrutinib monotherapy for ≥ 6 months | Experimental | Drug: Venetoclax combined with Zanubrutinib |
| CLL/SLL patients on acalabrutinib monotherapy for ≥ 6 months | Experimental | Drug: Venetoclax combined with Acalabrutinib |
| CLL/SLL patients on orelabrutinib monotherapy for ≥ 6 months | Experimental | Drug: Venetoclax combined with Orelabrutinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 1. Age: 18-80 years-old.
- 2. Patients must have a diagnosis of CLL/SLL.
- 3. Detectable MRD by flow cytometry (10^-4 sensitivity) in the peripheral blood.
- 4. Patients who are on BTK inhibitor monotherapy for more than 6 months. This study includes patients who are taking one of the following BTK inhibitors: ibrutinib, zanubrutinib, orelabrutinib, and acalabrutinib.
- 5. Patients need to have a response of at least PR (CR/PR) to BTK inhibitor monotherapy.
Key exclusion criteria (16 listed)
- 1. Richter transformation.
- 2. Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- 3. Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks prior to the first dose of the study drug.
- 4. Grade 3 or 4 hemorrhage within the past 3 weeks.
- 5. Uncontrolled active infections (viral, bacterial, and fungal).
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 |
|---|---|---|
| Venetoclax combined with IbrutinibAll Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using ibrutinib. After the completion of combination therapy, patients will stop both the ibrutinib and venetoclax then be followed. Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and ibrutinib will continue for an additional 12 cycles. Venetoclax and ibrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first. Ibrutinib is intended to be admistratered orally 420mg once daily. | Drug | CLL/SLL patients on ibrutinib monotherapy for ≥ 6 months |
| Venetoclax combined with ZanubrutinibAll Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using zanubrutinib. After the completion of combination therapy, patients will stop both the zanubrutinib and venetoclax then be followed. Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and zanubrutinib will continue for an additional 12 cycles. Venetoclax and zanubrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first. Zanubrutinib is intended to be admistratered orally 160mg twice daily. | Drug | CLL/SLL patients on zanubrutinib monotherapy for ≥ 6 months |
| Venetoclax combined with AcalabrutinibAll Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using acalabrutinib. After the completion of combination therapy, patients will stop both the acalabrutinib and venetoclax then be followed. Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and acalabrutinib will continue for an additional 12 cycles. Venetoclax and acalabrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first. Acalabrutinib is intended to be admistratered orally 100mg twice daily. | Drug | CLL/SLL patients on acalabrutinib monotherapy for ≥ 6 months |
| Venetoclax combined with OrelabrutinibAll Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using orelabrutinib. After the completion of combination therapy, patients will stop both the orelabrutinib and venetoclax then be followed. Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and orelabrutinib will continue for an additional 12 cycles. Venetoclax and orelabrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first. Orelabrutinib is intended to be admistratered orally 150mg once daily. | Drug | CLL/SLL patients on orelabrutinib monotherapy for ≥ 6 months |
Primary outcome
Rate of BM-uMRD after completion of combination therapy (Day 1 of Cycle 16)
Time frame: On Day 1 of Cycle 16 (each cycle is 28 days)
Rate of BM-uMRD is defined by negative MRD in the bone marrow by flow cytometry at a sensitivity of 10^-4. The Clopper Pearson method is used to estimate the 95% two-sided confidence interval (CI) of the rate of BM-uMRD.
6 secondary outcomes
Rate of undetected peripheral blood MRD by flow cytometry
Time frame: On screening, Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 16, Day 1 of Cycle 20, Day 1 of Cycle 24, Day 1 of Cycle 28 and Day 1 of Cycle 34 (each cycle is 28 days)
Rate of complete response (CR)
Time frame: On Day 1 of Cycle 7, Day 1 of Cycle 16, Day 1 of Cycle 22, and Day 1 of Cycle 28 (each cycle is 28 days)
Progression-free survival (PFS)
Time frame: From the first dose of venetoclax until the date of progression or date of death from any cause, whichever came first, assessed up to 112 months
Overall survival (OS)
Time frame: From the first dose of venetoclax until the date of death from any cause, assessed up to 112 months
Time to next treatment (TTNT)
Time frame: From the first dose of venetoclax to the next CLL-directed therapies due to progression, assessed up to 112 months
Adverse Events
Time frame: From screening to 30 days after the end of cycle 12 (each cycle is 28 days)
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 25 Nov 2025.
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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 2 study testing Venetoclax combined with Ibrutinib, Venetoclax combined with Zanubrutinib and Venetoclax combined with Acalabrutinib in people with Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL), run by The First Affiliated Hospital with Nanjing 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 19 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jianyong Li, PhD, MD (86-13951877733, lijianyonglm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of BM-uMRD after completion of combination therapy (Day 1 of Cycle 16) (time frame: On Day 1 of Cycle 16 (each cycle is 28 days)). 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 25 Nov 2025.