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

ConditionDLBCL
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial population

400

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Cohort 1: DLBCL patients diagnosed unfit/ Unfit.1 intervention
Group B: Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.1 intervention

Trial outcomes

Primary outcomes

1

EFS（Event-free survival）

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.

Time frame
2-year

Secondary outcomes

1

CRR（Complete response rate）

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.

Time frame
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
2

PFS（Progression-free survival）

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

Time frame
2-year
3

OS（Overall survival）

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

Time frame
2-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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