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NCT Number: NCT06779435

A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL

This is a prospective, observational, multicenter, cohort study with 400 newly treated DLBCL patients. To evaluate the clinical efficacy and safety of tucidinostat in the real-world treatment of primary diffuse large B-cell lymphoma

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

No. 197 Ruijin 2nd Road, Huangpu District, Shanghai

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Pengpeng Xu

CONTACT

[email protected]

13564015001

About this study

The study was divided into 2 cohorts. Cohort 1: DLBCL patients diagnosed unfit/ Unfit. A person who is unfit/ unfit is defined as being 80 years or older, or younger than 80 years old but has comorbidities and cannot tolerate a standard dose of chemotherapy as determined by the investigator. Reference options for a combination regimen include C-R2, C-R-mini-CHOP, etc.

Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit. Reference options for a combination regimen include CR-CHOP, C-Pola-R-CHP, etc.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age ≥18 years old, male or female;
  • 2. No previous treatment for DLBCL, including chemotherapy, targeted therapy and immunotherapy;
  • 3. DEL [Diffuse large B-cell lymphoma with double expression of MYC and BCL2 (immunohistochemical MYC≥40%, BCL2≥50%)] was confirmed by pathology; Or non-double expression but at least one of the following:;
  • TP53 or other epigenetic gene mutations (as in: ACTB, BCL6, BCOR, CREBBP, EP300, EZH2, HIST1H1C, HIST1H1E, HIST1H2BK, HIST2H2AB, IRF4, KMT2A, KMT2C, KMT2D, MYC, MYD88, NSD2, RAG1, SETD1B SF3B1, SIN3A, TBL1XR1, TET2, TOX, TP53, TRIP12, TRRAP, UBE2A)
  • MYC and BCL2 double hit
  • 4. Plan to receive or are receiving a treatment regimen containing tucidinostat (if it is permitted to start using tucidinostat after obtaining specific test results due to pending genetic sequencing results);
  • 5. Voluntarily sign informed consent.

Exclusion criteria

  • 1. Patients currently enrolled or planning to participate in any interventional clinical trial;
  • 2. The expected survival time is less than 6 months;
  • 3. There are any other reasons that the investigators believe are not suitable for patients to participate in this study.

Treatment and study plan

Low intensity treatment options

Drug

Reference options for a combined regimen include C-R2, C-R-mini-CHOP, etc.

Subjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. .Single-drug maintenance is recommended to last 24 weeks

Conventional immunochemotherapy regimen

Drug

Reference options for a combined regimen include CR-CHOP, C-Pola-R-CHP, etc.

Subjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. Single-drug maintenance is recommended to last 24 weeks

Primary outcomes

  1. EFS(Event-free survival)

    Time frame: 2-year

    The length of time from the start of treatment to the onset of disease progression, recurrence after CR, death from any cause, or the start of new therapy for residual lesions (including conversion therapy for lesions during the trial) after the end of combination therapy, whichever occurs first.

Secondary outcomes

  1. CRR(Complete response rate)

    Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

    The number of subjects who achieved complete response (CR) at the end of combination therapy as a percentage of the total number of participants in the analysis.

  2. PFS(Progression-free survival)

    Time frame: 2-year

    The length of time from the start of treatment to the onset of disease progression or recurrence or death from any cause, whichever occurs first

  3. OS(Overall survival)

    Time frame: 2-year

    From the start of treatment to the time of death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Pengpeng Xu, professor

CONTACT

[email protected]

13564015001

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of Diffuse Large B-cell Lymphoma

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 16, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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