Clinical trial · Interventional
Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL
A Phase 2 Trial of Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL
NCT03465527CI-TRIAL-00057508completedPhase 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)
A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PrednisoLONE 50 MG | Drug | Prednisolone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prednisolone
- description
- Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days Hydration, antibiotics, allopurinol, nutritional supplements, and so on.
- interventionNames
- Drug: PrednisoLONE 50 MG
Primary outcomes (1)
- measure
- (treatment-related mortality rate; TRM)
- timeFrame
- an average of 1 year
- description
- treatment-related mortality rate
Secondary outcomes (5)
- measure
- IMWG fragility score before and after pre-phase treatment
- timeFrame
- an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically the first large-scaled B-cell lymphoma patient 2. Diagnosis time 65 years old or older 3. Patients planning R-CHOP chemotherapy 4. Ann Arbor stage 2 (bulky ≥ diameter of 7cm), stage 3 or stage 4 5. The International Prognostic Index (IPI) is a high intermediate or high risk 6. Patients without prior history of lymphoma 7. The decision to participate voluntarily in this study and the written consent of the patient Exclusion Criteria: 1. Histologic subtypes other than CD20 positive broad-band macro-B cell lymphoma 2. Large B-cell lymphoma involving the central nervous system 3. Inadequate systemic disease A. Patients with clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia) or myocardial infarction within the past 6 months B. Serious neurological and psychiatric illness C. Serious active infection D. Other medical illnesses other than clinical trials 4. If the drug used in this study is allergic 5. If you do not agree to participate in the study
References
Publications (0)
Data not yet available
No reference posted for this study.