New hope for elderly lymphoma patients: drug combo shows promise in early trial
NCT ID NCT07397832
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This study tests a new combination of three drugs (chidamide, rituximab, and polatuzumab vedotin) in elderly patients with a specific type of untreated lymphoma called double-positive DLBCL. The goal is to see how many patients achieve complete remission after treatment. About 58 participants aged 70 and older (or 60-69 with limited fitness) will take part. This is an early-phase trial, so the main focus is on safety and effectiveness.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University Cancer Insititute & Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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