Clinical trial · Interventional
Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients
Prospective Exploratory Clinical Study of Orelabrutinib, Pomalidomide, Rituximab Combined With miniCHOP-like Regimen in Treatment-naive Elderly Patients With DLBCL
NCT05809180CI-TRIAL-00065820unknownN/AClinicalTrials.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)
The proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large B-cell lymphoma (DLBCL). This study intends to explore a new treatment pattern using Pro-miniCHOP-like regimen and simultaneously evaluate its safety and efficacy for future clinical practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orelabrutinib | Drug | — | UNRESOLVED |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
| Pro-miniCHOP-like regimen | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| R-miniCHOP-like regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
- description
- 1. Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day. 2. Phase II(stratified response therapy): Part A: (25% or more reduction): Patients receive Pro-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Pomalidomide on days 1-7, Orelabrutinib per day till progression or intolerant toxicity, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6). Part B: (reduction less than 25%): Patients receive R-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6). 3. Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years.
- interventionNames
- Drug: Rituximab
- Drug: Orelabrutinib
- Drug: Pomalidomide
- Drug: Pro-miniCHOP-like regimen
- Drug: R-miniCHOP-like regimen
Primary outcomes (2)
- measure
- Overall Response Rate(ORR) after Pro-miniCHOP-like regimen
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL; 2. There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter); 3. Age ≥ 70 years; 4. Life expectancy \>3 months; 5. Patients with proper organic function (alanine aminotransferase, bilirubin, creatinine \< 3 times the upper limit of normal; cardiac ejection fraction ≥ 50%; SPO2\>90% under non-oxygenated conditions). 6. Written informed consent obtained from the subject. Exclusion Criteria: 1. Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal); 2. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2); 3. Uncontrolled active infection; 4. Patients with central nervous system DLBCL; 5. A history of vascular embolism; 6. Co-existence of other tumors; 7. Systemic corticosteroid therapy is needed; 8. Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.
References
Publications (0)
Data not yet available
No reference posted for this study.