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New treatment option for Diffuse Large B-Cell Lymphoma (DLBCL)
Official title CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL
ClinicalTrials.gov ID: NCT07397832
What this study is testing
What is Chidamide?
Chidamide is an investigational medicine, being studied as a potential treatment for diffuse large b-cell lymphoma (dlbcl).
Also referred to as HDACi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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...
- Histopathological confirmation meeting all of the following conditions:
- Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20 positivity; concurrent positive expression of C-MYC and Bcl-2 (double-expressor...
- At least one measurable lesion positive on ¹⁸F-FDG PET-CT scan according to the Lugano 2014 criteria for Hodgkin and non-Hodgkin lymphoma.
You likely can't join if
- 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...
- Current diagnosis of any of the following: Follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL...
- History of myocardial infarction, unstable angina, or other clinically significant cardiac disease within 12 months prior to signing informed...
- Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage.
- Pregnant or lactating women.
See the full eligibility criteria
- 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...
- Histopathological confirmation meeting all of the following conditions:
- 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.
- 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):
- Hematology: Hb ≥90 g/L, ANC ≥1.5 × 10⁹/L, PLT ≥90 × 10⁹/L.
- Biochemistry: Cr ≤1.5 ×ULN; TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (for patients with liver involvement: ≤5 × ULN).
- Life expectancy of at least 6 months, as judged by the investigator.
- Ability to understand and voluntarily provide written informed consent.
- 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...
- 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...
- 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.
- Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage.
- Pregnant or lactating women.
- Participation in any other clinical trial within 6 months prior to signing informed consent.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.