Zanubrutinib, Chidamide, and Rituximab Induction With or Without CHOP Versus R-CHOP in Newly Diagnosed Double-Expressor DLBCL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLi Zhiming
About this trial
Zanubrutinib, as a new generation of BTK inhibitors, has shown more potent antitumor activity and lower adverse reactions than ibrutinib in head-to-head clinical studies, which make it a promising regimen for B cell lymphoma. Chidamide is an oral subtype-selective histone deacetylase inhibitor.
This Randomized, Multicenter, Open-Label Phase II Clinical Study is comparing the efficacy and safety of Zanubrutinib, Chidamide, and Rituximab induction therapy sequentially combined with or without CHOP versus R-CHOP in the first-line treatment of patients with newly diagnosed double-expressor DLBCL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed MYC/BCL2 double-expressor DLBCL confirmed by pathological histology/clinical imaging, with IHC BCL2 expression ≥50% and MYC expression ≥40%.
Male or female patients aged 18-65 years.
ECOG score of 0-2.
Expected survival time of ≥6 months.
Disqualifiers
Special types of DLBCL:Fluid overload-associated large B-cell lymphoma, primary mediastinal large B-cell lymphoma, mediastinal gray zone lymphoma, primary central nervous system (CNS) DLBCL, double-hit DLBCL with BCL2 and MYC rearrangements.
Transformed DLBCL (e.g., DLBCL transformed from follicular lymphoma, chronic lymphocytic leukemia/small B-cell lymphoma), secondary CNS involvement of DLBCL.
History of other malignancies within the past 5 years, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, and carcinoma in situ of the cervix.
Major surgery within the past 2 months (excluding diagnostic surgery).
Trial design
Design model
Parallel
Treatments tested in this trial
ZCR-CHOP
DrugZanubrutinib, Chidamide, and Rituximab Induction Therapy Sequentially Combined With or Without CHOP
R-CHOP
DrugR-CHOP
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: ZCR-CHOPExperimental treatment 1 intervention
Group B: R-CHOPActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
EOT-CR
defined as the proportion of subjects with measurable disease who achieve CR at the end of treatment according to 2014 Lugano criteria
Time frame
Approximately 12 monthsSecondary outcomes
1
EOT-ORR
defined as the proportion of subjects with measurable disease who achieve CR and PR at the end of treatment according to 2014 Lugano criteria
Time frame
Approximately 12 months2
Duration of response（DOR）
defined as the time from the date of first occurrence of CR or PR to the date of the first documented PD or death due to any cause according to 2014 Lugano criteria.
Time frame
Approximately 24 months3
Progression-free survival (PFS)
defined as the time from treatment to disease progression or death from any cause according to 2014 Lugano criteria.
Time frame
Approximately 24 months4
Overall survival (OS)
defined as the time from treatment to death from any cause according to 2014 Lugano criteria.
Time frame
Approximately 24 monthsOther outcomes
1
The consistency between ctDNA clearance and radiographic disease response
ctDNA will be collected from patients in the experimental group at baseline, the end of cycle 2, and the end of treatment. This includes, but is not limited to, evaluating the relationship between the clearance of the MYD88 L265P mutation and radiographic complete response after cycle 2 and at the end of treatment, as well as the relationship between the clearance of TP53 mutations and radiographic complete response.
Time frame
Approximately 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Li Zhiming
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: