Diffuse Large B-Cell LymphomaPhase 2DEL-MRD-CHIDNCT07507318
Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission
A Phase 2 study testing Chidamide in people with Diffuse Large B-Cell Lymphoma, run by Rong Tao at 1 site in China.
Trial summary
This is a prospective, multicenter, single-arm, open-label phase 2 study designed to evaluate the efficacy and safety of chidamide maintenance in adults with newly diagnosed double-expressor diffuse large B-cell lymphoma (DLBCL) who achieve complete response after induction therapy but remain ctDNA minimal residual… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2026to 30 Jun 2029
- 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
- Histologically confirmed diffuse large B-cell lymphoma, CD20-positive.
- Double-expressor lymphoma confirmed by pathology, defined as MYC expression >=40% and BCL2 expression >=50% by immunohistochemistry.
- Complete response after initial induction therapy.
- Age >=18 and <=80 years.
- ECOG performance status 0-2.
- No prior history of malignant tumor and no concurrent malignancy.
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- International Prognostic Index (IPI) score >1.
- ctDNA MRD-positive at screening/enrollment.
- Life expectancy of at least 6 months, in the opinion of the investigator.
- Written informed consent provided before any study-specific procedure.
Who cannot join
- Failure to achieve complete response after initial induction therapy.
- Prior organ transplantation.
- Uncontrolled coagulopathy or active bleeding.
- Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction <50%, connective tissue disease, or severe active infection.
- Major organ surgery within 6 weeks before screening.
- Screening laboratory abnormalities not attributable to lymphoma, including: neutrophil count <1.5 x 10^9/L; platelet count <80 x 10^9/L (or <50 x 10^9/L in patients with bone marrow involvement); total bilirubin >1.5 x upper limit of normal; ALT/AST >2.5 x upper limit of normal, or >5 x upper limit of normal in patients with hepatic involvement; serum creatinine >1.5 x upper limit of normal.
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- Active hepatitis B not meeting protocol-defined virologic criteria for enrollment; patients with positive HBsAg or positive HBcAb require HBV DNA testing and must meet protocol-specified thresholds.
- HIV infection.
- Ongoing antitumor therapy for lymphoma or another malignancy.
- Drug abuse or chronic alcohol abuse that may interfere with study evaluation.
- Psychiatric illness or any condition resulting in inability to comply with the protocol.
- Requirement for ongoing treatment with strong or moderate CYP3A inhibitors or inducers; patients exposed to these agents within 7 days before first study dose, or within fewer than 5 half-lives, are not eligible.
- Inability to swallow capsules or clinically significant gastrointestinal disorders that may affect drug absorption, including malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial/complete bowel obstruction.
- Any other uncontrolled medical condition that, in the investigator's judgment, may compromise safety, interfere with oral drug absorption or metabolism, or place the participant at excessive risk.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 20000
Rong Tao, MD, 008621-64175590, rtao@shca.org.cn
Wenhan Zhang, MD, 008621-64175590, zhangwenhao@shca.org.cn
About this study
Official title: A Prospective, Multicenter, Single-Arm, Open-Label Phase 2 Study of Chidamide Maintenance in Patients With Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma Who Achieve Complete Response After Induction Therapy But Remain ctDNA MRD-Positive
This is a prospective, multicenter, single-arm, open-label phase 2 study designed to evaluate the efficacy and safety of chidamide maintenance in adults with newly diagnosed double-expressor diffuse large B-cell lymphoma (DLBCL) who achieve complete response after induction therapy but remain ctDNA minimal residual disease (MRD)-positive. Eligible participants will receive oral chidamide 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be assessed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The primary objectives are to evaluate ctDNA MRD negativity and 2-year progression-free survival. Secondary objectives include event-free survival, overall survival, and safety.
Read the detailed description
Patients with double-expressor DLBCL remain at increased risk of relapse despite achieving complete response after induction therapy. ctDNA-based MRD assessment may identify a subgroup with persistent molecular disease who are at particularly high risk for recurrence. Chidamide is an oral selective histone deacetylase inhibitor with potential antitumor and immune-modulating activity in B-cell lymphomas.
This prospective, multicenter, single-arm, open-label phase 2 study will enroll adult patients with newly diagnosed CD20-positive double-expressor DLBCL, defined by MYC expression >=40% and BCL2 expression >=50% by immunohistochemistry, who achieve complete response after initial induction therapy but remain ctDNA MRD-positive. Participants will receive chidamide 20 mg orally on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be monitored every 12 weeks. Treatment will stop upon two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The study will evaluate ctDNA MRD negativity rate and 2-year progression-free survival as primary endpoints, with event-free survival, overall survival, and safety as secondary endpoints.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Chidamide
- Keywords
- Chidamide, Tucidinostat, Minimal Residual Disease, Maintenance Therapy, Double-Expressor Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Chidamide 20 mg orally on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD assessments will be performed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments at least 3 months apart, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide Maintenance | Experimental | Participants with newly diagnosed double-expressor DLBCL who achieve complete response after induction therapy but remain ctDNA MRD-positive will receive chidamide maintenance therapy. Receives: Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA MRD Negativity Rate
The proportion of enrolled participants who convert from ctDNA MRD-positive status at study entry to ctDNA MRD-negative status during chidamide maintenance, based on the protocol-specified ctDNA assay.
Measured: From first dose up to 24 months
2-Year Progression-Free Survival Rate
The proportion of enrolled participants who are alive and free of disease progression 24 months after study entry.
Measured: 24 months after study entry
Secondary outcomes (3)
Event-Free Survival
Time from study entry to disease progression, initiation of new antitumor therapy, or death from any cause.
Measured: From study entry up to 24 months
Overall Survival
Time from study entry to death from any cause.
Measured: From study entry up to 24 months
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Incidence of hematologic and non-hematologic adverse events and serious adverse events, graded according to NCI CTCAE version 5.0.
Measured: From first dose to 30 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start16 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (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 Diffuse Large B-Cell LymphomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rong Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rong Tao, Fudan University
- Investigators
- Rong Tao, MD & PhD, Study chair, Fudan UniversityWenhao Zhang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507318
- Sponsor's protocol ID
- DEL-MRD-CHID-2026
- Acronym
- DEL-MRD-CHID
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding sharing de-identified individual participant data has not yet been made. This is an investigator-initiated, multicenter study involving ctDNA MRD-related data, and the sponsor has not yet finalized the data-sharing governance, de-identification standards, request review process, and applicable data-sharing agreements across participating sites. The possibility of sharing de-identified data may be considered after study completion and database lock, in accordance with participant consent, ethics committee requirements, institutional policies, and applicable regulations.
Publications
Krupka JA, Moutsopoulos I, Cutmore NH, Trethewey CS, Dayimu A, Goodhew R, Kaji F, Raso-Barnett L, Cheow H, Elzubeir L, Smith J, Kamil A, Barbara RR, Price J, Elston K, Kolodziejczyk A, Tarantino S, Mariscotti F, Barry P, Frost S, Demiris N, Thomas MG, Hassane D, Munugalavadla V, Nagumantry SK, Karanth MJ, Ahearne M, Shah N, Fox CP, Anand S, Hodson DJ. Phased Variant-Supported Circulating Tumor DNA as a Prognostic Biomarker After First-Line Treatment in Large B-Cell Lymphoma: Findings From the DIRECT Study. J Clin Oncol. 2026 Feb 10;44(5):410-420. doi: 10.1200/JCO-25-01587. Epub 2025 Dec 22.
PubMed 41428995Roschewski M, Kurtz DM, Westin JR, Lynch RC, Gopal AK, Alig SK, Sworder BJ, Cherng HJ, Kuffer C, Blair D, Brown K, Goldstein JS, Schultz A, Close S, Chabon JJ, Diehn M, Wilson WH, Alizadeh AA. Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma. J Clin Oncol. 2025 Dec;43(34):3652-3661. doi: 10.1200/JCO-25-01534. Epub 2025 Aug 13.
PubMed 40802906Johnson NA, Slack GW, Savage KJ, Connors JM, Ben-Neriah S, Rogic S, Scott DW, Tan KL, Steidl C, Sehn LH, Chan WC, Iqbal J, Meyer PN, Lenz G, Wright G, Rimsza LM, Valentino C, Brunhoeber P, Grogan TM, Braziel RM, Cook JR, Tubbs RR, Weisenburger DD, Campo E, Rosenwald A, Ott G, Delabie J, Holcroft C, Jaffe ES, Staudt LM, Gascoyne RD. Concurrent expression of MYC and BCL2 in diffuse large B-cell lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. J Clin Oncol. 2012 Oct 1;30(28):3452-9. doi: 10.1200/JCO.2011.41.0985. Epub 2012 Jul 30.
PubMed 22851565Rosenthal A, Younes A. High grade B-cell lymphoma with rearrangements of MYC and BCL2 and/or BCL6: Double hit and triple hit lymphomas and double expressing lymphoma. Blood Rev. 2017 Mar;31(2):37-42. doi: 10.1016/j.blre.2016.09.004. Epub 2016 Sep 30.
PubMed 27717585
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm, Open-Label Phase 2 Study of Chidamide Maintenance in Patients With Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma Who Achieve Complete Response After Induction Therapy But Remain ctDNA MRD-Positive
- ClinicalTrials.gov ID
- NCT07507318
- Acronym / sponsor ID
- DEL-MRD-CHID / DEL-MRD-CHID-2026
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- Chidamide, Tucidinostat, Minimal Residual Disease, Maintenance Therapy, Double-Expressor Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Rong TaoUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 2 Apr 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.
This is a prospective, multicenter, single-arm, open-label phase 2 study designed to evaluate the efficacy and safety of chidamide maintenance in adults with newly diagnosed double-expressor diffuse large B-cell lymphoma (DLBCL) who achieve complete response after induction therapy but remain ctDNA minimal residual disease (MRD)-positive. Eligible participants will receive oral chidamide 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be assessed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The primary objectives are to evaluate ctDNA MRD negativity and 2-year progression-free survival. Secondary objectives include event-free survival, overall survival, and safety.
Detailed description
Patients with double-expressor DLBCL remain at increased risk of relapse despite achieving complete response after induction therapy. ctDNA-based MRD assessment may identify a subgroup with persistent molecular disease who are at particularly high risk for recurrence. Chidamide is an oral selective histone deacetylase inhibitor with potential antitumor and immune-modulating activity in B-cell lymphomas.
This prospective, multicenter, single-arm, open-label phase 2 study will enroll adult patients with newly diagnosed CD20-positive double-expressor DLBCL, defined by MYC expression >=40% and BCL2 expression >=50% by immunohistochemistry, who achieve complete response after initial induction therapy but remain ctDNA MRD-positive. Participants will receive chidamide 20 mg orally on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be monitored every 12 weeks. Treatment will stop upon two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The study will evaluate ctDNA MRD negativity rate and 2-year progression-free survival as primary endpoints, with event-free survival, overall survival, and safety as secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide Maintenance | Experimental | Drug: ChidamideParticipants with newly diagnosed double-expressor DLBCL who achieve complete response after induction therapy but remain ctDNA MRD-positive will receive chidamide maintenance therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed diffuse large B-cell lymphoma, CD20-positive.
- Double-expressor lymphoma confirmed by pathology, defined as MYC expression >=40% and BCL2 expression >=50% by immunohistochemistry.
- Complete response after initial induction therapy.
- Age >=18 and <=80 years.
- ECOG performance status 0-2.
Key exclusion criteria (14 listed)
- Failure to achieve complete response after initial induction therapy.
- Prior organ transplantation.
- Uncontrolled coagulopathy or active bleeding.
- Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction <50%, connective tissue disease, or severe active infection.
- Major organ surgery within 6 weeks before screening.
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 |
|---|---|---|
| ChidamideChidamide 20 mg orally on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD assessments will be performed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments at least 3 months apart, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. | Drug | Chidamide Maintenance |
Primary outcome
ctDNA MRD Negativity Rate
Time frame: From first dose up to 24 months
The proportion of enrolled participants who convert from ctDNA MRD-positive status at study entry to ctDNA MRD-negative status during chidamide maintenance, based on the protocol-specified ctDNA assay.
2-Year Progression-Free Survival Rate
Time frame: 24 months after study entry
The proportion of enrolled participants who are alive and free of disease progression 24 months after study entry.
3 secondary outcomes
Event-Free Survival
Time frame: From study entry up to 24 months
Overall Survival
Time frame: From study entry up to 24 months
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: From first dose to 30 days after last dose.
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 18 Jun 2026.
- Results publication: PubMed 41428995Krupka JA, Moutsopoulos I, Cutmore NH, Trethewey CS, Dayimu A, Goodhew R, Kaji F, Raso-Barnett L, Cheow H, Elzubeir L, Smith J, Kamil A, Barbara RR, Price J, Elston K, Kolodziejczyk A, Tarantino S, Mariscotti F, Barry P, Frost S, Demiris N, Thomas MG, Hassane D, Munugalavadla V, Nagumantry SK, Karanth MJ, Ahearne M, Shah N, Fox CP, Anand S, Hodson DJ. Phased Variant-Supported Circulating Tumor DNA as a Prognostic Biomarker After First-Line Treatment in Large B-Cell Lymphoma: Findings From the DIRECT Study. J Clin Oncol. 2026 Feb 10;44(5):410-420. doi: 10.1200/JCO-25-01587. Epub 2025 Dec 22.
- Results publication: PubMed 40802906Roschewski M, Kurtz DM, Westin JR, Lynch RC, Gopal AK, Alig SK, Sworder BJ, Cherng HJ, Kuffer C, Blair D, Brown K, Goldstein JS, Schultz A, Close S, Chabon JJ, Diehn M, Wilson WH, Alizadeh AA. Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma. J Clin Oncol. 2025 Dec;43(34):3652-3661. doi: 10.1200/JCO-25-01534. Epub 2025 Aug 13.
- Results publication: PubMed 22851565Johnson NA, Slack GW, Savage KJ, Connors JM, Ben-Neriah S, Rogic S, Scott DW, Tan KL, Steidl C, Sehn LH, Chan WC, Iqbal J, Meyer PN, Lenz G, Wright G, Rimsza LM, Valentino C, Brunhoeber P, Grogan TM, Braziel RM, Cook JR, Tubbs RR, Weisenburger DD, Campo E, Rosenwald A, Ott G, Delabie J, Holcroft C, Jaffe ES, Staudt LM, Gascoyne RD. Concurrent expression of MYC and BCL2 in diffuse large B-cell lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. J Clin Oncol. 2012 Oct 1;30(28):3452-9. doi: 10.1200/JCO.2011.41.0985. Epub 2012 Jul 30.
- Results publication: PubMed 27717585Rosenthal A, Younes A. High grade B-cell lymphoma with rearrangements of MYC and BCL2 and/or BCL6: Double hit and triple hit lymphomas and double expressing lymphoma. Blood Rev. 2017 Mar;31(2):37-42. doi: 10.1016/j.blre.2016.09.004. Epub 2016 Sep 30.
- Individual participant dataSharing planned: Undecided. A decision regarding sharing de-identified individual participant data has not yet been made. This is an investigator-initiated, multicenter study involving ctDNA MRD-related data, and the sponsor has not yet finalized the data-sharing governance, de-identification standards, request review process, and applicable data-sharing agreements across participating sites. The possibility of sharing de-identified data may be considered after study completion and database lock, in accordance with participant consent, ethics committee requirements, institutional policies, and applicable regulations.
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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.
Rong Tao, MD & PhD study chair
Fudan University
Wenhao Zhang, MD principal investigator
Fudan University
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 Chidamide in people with Diffuse Large B-Cell Lymphoma, run by Rong Tao 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 10 inclusion and 14 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 18 Jun 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 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 Rong Tao, MD & PhD (008621-64175590, rao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA MRD Negativity Rate (time frame: From first dose up to 24 months). The study lists 2 primary outcomes in all. 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 NCT07507318, 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 18 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.