NCT07397832 CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL
| NCT ID | NCT07397832 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Diffuse Large B-Cell Lymphoma (DLBCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2028-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 58 participants in total. It began in 2026-01-30 with a primary completion date of 2028-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. 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. 2. 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). 3. Histopathological confirmation meeting all of the following conditions: 1. Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20 positivity; concurrent positive expression of C-MYC and Bcl-2 (double-expressor phenotype). 2. At least one measurable lesion positive on ¹⁸F-FDG PET-CT scan according to the Lugano 2014 criteria for Hodgkin and non-Hodgkin lymphoma. 4. Laboratory tests at screening must meet the following criteria, unless the investigator attributes abnormalities to lymphoma (no corrective or supportive therapy for these parameters within 2 weeks prior to assessment): 1. Hematology: Hb ≥90 g/L, ANC ≥1.5 × 10⁹/L, PLT ≥90 × 10⁹/L. 2. Biochemistry: Cr ≤1.5 ×ULN; TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (for patients with liver involvement: ≤5 × ULN). 5. Life expectancy of at least 6 months, as judged by the investigator. 6. Ability to understand and voluntarily provide written informed consent. Exclusion Criteria: 1. History of or concurrent other active malignancies. 2. 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. 3. 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. 4. 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. 5. Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage. 6. Pregnant or lactating women. 7. Participation in any other clinical trial within 6 months prior to signing informed consent. 8. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
Contact & Investigator
Huilai Zhang
STUDY DIRECTOR
Tianjin Medical University Cancer Insititute & Hospital
Frequently Asked Questions
Who can join the NCT07397832 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Diffuse Large B-Cell Lymphoma (DLBCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07397832 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07397832 currently recruiting?
Yes, NCT07397832 is actively recruiting participants. Contact the research team at huilaizhangtz@163.com for enrollment information.
Where is the NCT07397832 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07397832 clinical trial?
NCT07397832 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The principal investigator is Huilai Zhang at Tianjin Medical University Cancer Insititute & Hospital. The trial plans to enroll 58 participants.