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Diffuse Large B-cell LymphomaPhase 3DEBNCT04231448

Phase III Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed Double-Expressor DLBCL

A Phase 3 study testing R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) and Tucidinostat in people with Diffuse Large B-cell Lymphoma, run by Chipscreen Biosciences, Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. This Randomized, Double-blind, Placebo-controlled Phase 3 trail is studying the efficacy and safety of Tucidinostat, in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)… 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?
R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) and Tucidinostat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
423 participants
Where
2 sitesChina
Study dates
21 May 2020to 29 Jun 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Each potential subject must satisfy all of the following criteria to be enrolled in the study.
  • Male or female, age ≥ 18 years and ≤80 years.
  • No prior treatment for diffuse large B cell lymphoma(DLBCL), including hemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy)
  • Histological or cytological confirmation of DLBCL
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  • CD20-positive DLBCL;
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  • Myc≥40% as well as Bcl-2≥50% through immunohistochemistry;
  • Not with double (BCL-2 and c-MYC gene rearrangement) or triple (BCL-2, BCL-6, and c-MYC gene rearrangement) hit by FISH.
  • The verification of DLBCL will be based on local pathology report.15-20 unstained slides must be sent to the central laboratory for retrospective confirmation.
  • 4.At least one positive lesion according to the Lugano Classification by fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography(CT).
  • 5.Lymphoma International PrognosisIndex (IPI) score of 2,3,4. 6.Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2. 7.Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry):
  • (1)Hematology values:Hemoglobin (Hb)≥90g/L ; Absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L (2)Biochemical values: Serum creatinine ≤1.5×upper limit of normal(ULN); Total bilirubin ≤1.5 × ULN; Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤2.5×ULN(ALT,AST≦5×ULN if liver involved).
  • 8.Expected survival≥6 months. 9.All patients must have signed an informed consent document.

Who cannot join

  • Any potential subject who meets any of the following criteria will be excluded from participating in the study.
  • Presence of CNS involvement.
  • Patients with primary DLBCL of the central nervous system (CNS),or secondary lymphoma of the central nervous system, or Primary mediastinal (thymic) large B-cell lymphoma, or Primary effusion lymphoma, or B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma, or Primary cutaneous DLBCL, leg type, or indolent lymphoma, or Burkitt lymphoma, or EBV-positive mucocutaneous ulcer, or DLBCL associated with chronic inflammation, or Lymphomatoid granulomatosis, or Intravascular large B-cell lymphoma, or ALK-positive large B-cell lymphoma, or Plasmablastic lymphoma, or HHV8-positive DLBCL, NOS, or primary testicular DLBCL.
  • Patients with transformed lymphoma.
  • History of organ transplantation or hematopoietic stem cell transplantation.
  • Patients planned for autologous or allogeneic transplant as consolidation in first line.
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  • Patients with any other malignancy, except patients with a history of curatively treated basal or squamous cell carcinoma or in situ carcinoma of the cervix at any time prior to the study are eligible.
  • Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody within 5 years of the start of Cycle 1.
  • Prior use of any monoclonal antibody within 3 months of the start of Cycle 1.
  • Any investigational therapy within 3 months prior to the start of Cycle 1.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
  • Contraindication to any of the individual components of CHOP.
  • Corticosteroid use > 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control:
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  • Patients receiving corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to randomization (Cycle 1, Day 1).
  • If glucocorticoid treatment is urgently required for lymphoma symptom control prior to the start of study treatment, prednisone 100 mg or equivalent could be given for a maximum of 5 days, but all tumor assessments must be completed prior to start of glucocorticoid treatment.
  • 13.Ongoing serious central nervous system disease or peripheral neuropathy, such as progressive multifocal leukoencephalopathy.
  • 14.Have uncontrolled or significant cardiovascular disease, including:
  • Grade II or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (New York Heart Association Functional Classification ) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) < 50% during screening stage.
  • Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al).
  • History of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male), QTc≥470ms（female）at screening.
  • Symptomatic coronary heart disease requiring treatment.
  • Any other cardiovascular disease which is inappropriate for the study according to investigators' judgment.
  • 15.History of interstitial lung disease(ILD), or with ongoing signs and symptoms by CT or MRI at the time of screening.
  • 16.Patients with factors that could affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy.
  • 17.History of deep vein thrombosis or pulmonary embolism. 18.History of active bleeding within 2 months prior to the start of Cycle 1;or patients receiving anticoagulation therapy; or patients with evidence of bleeding potential according to investigators' judgment ( esophageal varices, active ulcer, or fecal occult blood test positive etc. ). Patients with bleeding led by lymphoma according to investigators' judgment are eligible.
  • 19.6 weeks or less from the last major surgery that involved crucial organs, or with any other factors impede postoperative recovery according to investigators' judgment.
  • 20.Known active infection, or active and uncontrolled hepatitis B infection(HBV), hepatitis C Virus(HCV), human immunodeficiency virus (HIV)/AIDS (Acquired Immune Deficiency Syndrome), or any other serious infection. (active infection defined as any major episode of infection requiring systemic treatment; Patients with occult or prior HBV may be included if HBV DNA is undetectable.) 21.Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or limit compliance with study requirements/ treatment.
  • 22.Drug or alcohol abuse. 23.Women of childbearing potential and men who are sexually active not willing to practice a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials.These restrictions apply for 12 months after the last dose of rituximab or 12 weeks after the last dose of study drug, whichever is later. Pregnancy or lactation.
  • 24.Any other condition which is inappropriate for the study according to investigators' judgment.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality

  • Shanghai JiaoTong University School of Medicine，Ruijin Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed MYC/BCL2 Double-Expressor DLBCL

Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. This Randomized, Double-blind, Placebo-controlled Phase 3 trail is studying the efficacy and safety of Tucidinostat, in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed MYC/BCL2 Double-Expressor Diffuse Large B-cell Lymphoma.

Read the detailed description

The primary objective is to evaluate if the addition of Tucidinostat to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) prolongs event-free survival (EFS) compared with R-CHOP alone in subjects with newly diagnosed MYC/BCL2 Double-Expressor subtype of DLBCL selected by IHC and FISH.

Being tested
R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone), Tucidinostat, Placebo
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone)Drug

    R-CHOP : rituximab 375 mg/m2 IV, cyclophosphamide 750 mg/m2 IV, doxorubicin 50 mg/m2 IV, vincristine 1.4 mg/m2 IV [maximum total 2 mg], and prednisone [or equivalent] 100 mg orally as the background therapy for 6 cycles (21 days/cycle).

  • TucidinostatDrug

    Tucidinostat ：30 mg was given orally after breakfast on day 1, day 4, day 8, day 11 in a 21-day cycle，for 6 cycles. After cycle 6 patients who are evaluated as complete response will receive 24 weeks additional administrations of Tucidinostat on day 1, day 4, day 8, day 11 in a 21-day cycle.

  • PlaceboDrug

    Placebo：30 mg was given orally after breakfast on day 1, day 4, day 8, day 11 in a 21-day cycle，for 6 cycles. After cycle 6 patients who are evaluated as complete response will receive 24 weeks additional administrations of placebo on day 1, day 4, day 8, day 11 in a 21-day cycle.

Study groups in NCT04231448
Study groupRoleWhat they receive
CR-CHOPExperimentalNot described
Receives: Drug: R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone); Drug: Tucidinostat
R-CHOPPlacebo comparatorNot described
Receives: Drug: R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival (EFS)

    Defined as the duration from the date of randomization to the date of disease progression, relapse from CR , initiation of subsequent systemic antilymphoma therapy for residual disease, or death, whichever occurs first.

    Measured: Up to approximately 5 years

Secondary outcomes (5)

  1. Complete Response Rate(CRR)

    Defined as the proportion of subjects with measurable disease who achieve CR.

    Measured: Up to approximately 3 years

  2. Progression-Free Survival (PFS)

    Defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first.

    Measured: Up to approximately 5 years

  3. Overall Survival (OS)

    defined as the duration from the date of randomization to the date of the participant's death

    Measured: Up to approximately 5 years

  4. Disease-Free Survival (DFS)

    Defined for patients achieving CR as the period from the date of the initial CR until the date of relapse or death from any cause.

    Measured: Up to approximately 5 years

  5. Safety of Tucidinostat when combined with R-CHOP

    All adverse events occurring during or after the first treatment will be summarized by treatment arm and NCI CTCAE grade.

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start21 May 2020
  3. Primary completion10 Jan 2023
  4. Study completion29 Jun 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
423 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04231448
Sponsor's protocol ID
CDM302
Acronym
DEB
Status last verified
Apr 2026
First submitted
14 Jan 2020
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu PP, Song YQ, Shen JZ, Cai QQ, Zhou H, Zhang LL, Xiang Y, Sun XH, Yang W, Yao ZH, Jing HM, Wen SJ, Jin J, Xue HW, Cen H, Ding KY, Jin ZM, Liu LH, Xing XJ, Li LF, Hou M, Liu L, Zhang MZ, Li WY, Bai O, Feng R, Zhu ZM, Wu HJ, Su LP, Gao L, Li F, Huang WR, Liu P, Yan XJ, Zhao Y, Su H, Zhao XL, Fu R, Liu H, Shi WY, Li HZ, Chen B, Ning ZQ, Zhu J, Zhao WL. Tucidinostat Plus R-CHOP vs R-CHOP in MYC/BCL2 Double-Expressor Diffuse Large B-Cell Lymphoma: A Randomized Clinical Trial. JAMA. 2026 May 19;335(19):1684-1693. doi: 10.1001/jama.2026.4199.

    PubMed 42018318

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) and Tucidinostat in people with Diffuse Large B-cell Lymphoma, run by Chipscreen Biosciences, Ltd. at 2 sites 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 13 inclusion and 30 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: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (EFS) (time frame: Up to approximately 5 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 NCT04231448, which also lists 1 linked publication.

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 8 Apr 2026.

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