NCT07507318

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
38mo left

Started Apr 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Jun 2029

First Submitted

Initial submission to the registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 27, 2026

Last Update Submit

March 27, 2026

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

ChidamideTucidinostatMinimal Residual DiseaseMaintenance TherapyDouble-Expressor Lymphoma

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    24 months after study entry

Secondary Outcomes (3)

  • Event-Free Survival

    From study entry up to 24 months

  • Overall Survival

    From study entry up to 24 months

  • Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events

    From first dose to 30 days after last dose.

Study Arms (1)

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.

Drug: Chidamide

Interventions

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.

Chidamide Maintenance

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 20000, China

Location

Related Publications (4)

  • 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.

    PMID: 41428995RESULT

  • Roschewski 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.

    PMID: 40802906RESULT

  • Johnson 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.

    PMID: 22851565RESULT

  • Rosenthal 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.

    PMID: 27717585RESULT

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseNeoplasm, Residual

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rong Tao, MD & PhD

    Fudan University

    STUDY CHAIR

  • Wenhao Zhang, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Tao, MD & PhD

CONTACT

008621-64175590rao@shca.org.cn

Wenhao Zhang, MD

CONTACT

008621-64175590zhangwenhao@shca.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD & PhD

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

CN(1)