Clinical trial · Interventional
Chidamide Plus R-CHOP in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes
Chidamide Plus R-CHOP (CR-CHOP) in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes: A Prospective, Multicenter Phase II Trial
NCT06891157CI-TRIAL-00087581recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the Safety and Efficacy of CR-CHOP Treatment in Newly Diagnosed Double-Expressor DLBCL with Other Molecular Subtypes
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chidamide | — | UNRESOLVED | — |
| DLBCL - Diffuse Large B Cell Lymphoma | Interdigitating Dendritic Cell Sarcoma | PROBABILISTIC | 0.70 |
| Double-expressor Lymphoma (DEL) | Double-Expressor Lymphoma | ONTOLOGY_EXACT | 0.85 |
| R-CHOP Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide plus R-CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CR-CHOP arm
- description
- Newly Diagnosed DEL Patients Receiving Chidamide plus R-CHOP(Rituximab、Cyclophosphamide、Doxorubicin、Vincristine and Prednisone) Regimen Treatment
- interventionNames
- Drug: Chidamide plus R-CHOP
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 2 years
- description
- from date of inclusion to date of progression, relapse, or death from any cause
Secondary outcomes (3)
- measure
- CR rate
- timeFrame
- up to 6 cycles (each cycle is 21 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must meet all of the following inclusion criteria to be eligible for enrollment:
1. ≥18 years of age;
2. Diffuse large B-cell lymphoma diagnosed by pathological diagnosis according to WHO 2016 classification criteria;
3. Molecular subtyping, determined through high-throughput sequencing of pathological tissue or peripheral blood, is categorized as the "Other" subtype;
4. Immunohistochemistry revealed overexpression of MYC and BCL2: MYC ≥ 40%, BCL2 ≥ 50%;
5. Measurable lesions identified on cross-sectional imaging through diagnostic modalities (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) are defined as the presence of at least one two-dimensional lesion with a maximum cross-sectional diameter (GTD) ≥1.5 cm, irrespective of the short-axis diameter;
6. The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤2;
7. Adequate hepatic function is defined as: total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN; alkaline phosphatase (ALP) ≤ 5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 35 mL/min as calculated by the Cockcroft-Gault formula;
8. Voluntary participation with willingness to provide the aforementioned treatment data, accompanied by a signed and dated informed consent form.
Exclusion Criteria:
* Patients who meet any of the following criteria will be excluded from the study:
1. Currently enrolled in another clinical trial;
2. Received prior lymphoma treatment with alternative regimens before enrollment;
3. Presence of concurrent malignant tumors;
4. Deemed ineligible for participation by the investigator's judgment;
5. Presence of severe psychiatric or neurological disorders that may impair the ability to provide informed consent and/or affect the reporting or observation of adverse events;
6. Patients unable to comply with follow-up requirements;
7. Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
8. Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive and HBV DNA positive), HCV positiveReferences
Publications (0)
Data not yet available
No reference posted for this study.