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CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL

ConditionDiffuse Large B-Cell Lymphoma (DLBCL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥70 years, or patients aged 60-69 years with an ECOG performance status score of 2-4. Both males and females are eligible.

No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy directed at the lymphoma (excluding palliative radiotherapy for symptom relief), or surgical therapy (excluding diagnostic biopsy or surgery not targeting the lymphoma).

Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20 positivity; concurrent positive expression of C-MYC and Bcl-2 (double-expressor phenotype).

At least one measurable lesion positive on ¹⁸F-FDG PET-CT scan according to the Lugano 2014 criteria for Hodgkin and non-Hodgkin lymphoma.

Disqualifiers

History of or concurrent other active malignancies.

Prior treatment with Chidamide and/or R-CHOP. Contraindication to any component of CHOP, including prior anthracycline therapy. History of severe hypersensitivity or anaphylaxis to humanized or murine monoclonal antibodies, or known sensitivity/allergy to murine products.

Current diagnosis of any of the following: Follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma); Primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; Central nervous system (CNS) lymphoma (primary or secondary); Primary effusion DLBCL; Primary cutaneous DLBCL, leg type.

History of myocardial infarction, unstable angina, or other clinically significant cardiac disease within 12 months prior to signing informed consent; or prior coronary angioplasty/stenting within 12 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • Chidamide

    Drug

    Chidamide: patients followed a step-dose escalation regimen (10mg BIW,15mg BIW, 20mg BIW). 21 days as a treatment cycle. The maximum number of treatment cycles is six.

  • Rituximab

    Drug

    Day 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six.

  • Polatuzumab Vedotin

    Drug

    Day 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six.

  • Chidamide Maintenance

    Drug

    For patients assessed as being in PR or CR status after completion of combination therapy, maintenance therapy with chidamide is administered for one year at a dosage of 20 mg, BIW. Drug adjustments may be made based on the patient's tolerance, with reference to the drug prescribing information.

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide MaintenExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Complete Response Rate (CRR)

To assess the Complete Response Rate (CR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin).

Time frame
up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days

Secondary outcomes

1

Overall Response Rate (ORR)

To assess the Overall Response Rate (ORR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin).

Time frame
up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days
2

Progression-free survival (PFS)

The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first."

Time frame
up to 2 years
3

Event free survival(EFS)

The duration from the time of study enrollment until the occurrence of disease progression, relapse after complete response (CR), death from any cause, or the initiation of new treatment for residual lesions after completion of combination therapy (including switched therapy for lesions during the trial), whichever occurs first.

Time frame
up to 2 years
4

Overall Survival(OS)

The time from subject enrollment to Death caused by any reason. for patients lost to follow-up, the time of the last follow-up; for patients still alive at the end of study, the date of the end of follow-up.

Time frame
up to 2 years

Other outcomes

1

Biomarkers Associated with Treatment Response and Disease Progression

Using Whole Transcriptome Sequencing (WTS) and Next-Generation Sequencing (NGS), we will examine if baseline molecular/proteomic subtypes, genomic profiles, and specific somatic mutations affect CRP regimen efficacy or drive disease progression to more severe states.

Time frame
up to 2 years
2

Biomarkers Associated with Adverse Events

We will use Whole Transcriptome Sequencing (WTS) and NGS to investigate whether specific somatic mutations increase the risk of CRP regimen-related adverse events.

Time frame
up to 2 years

Sponsors and contacts

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

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov
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