Clinical trial · Interventional
R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients
Prospective, Multicentre Phase II Study With R-CHOP- 14 or R-CHOP-21 & Consolidation PET-Oriented Radiotherapy (RT) in Diffuse Large B Cell Lymphoma (DLBCL) Patients With Low Risk Profile According to Age-adjusted IPI (0 With Bulky or 1)
NCT03364439CI-TRIAL-00056854FIL_DLCL10completedPhase 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)
Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 \& consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients
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 |
|---|---|---|---|
| Treatment plan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- One arm for all patients
- description
- Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21.
- interventionNames
- Drug: Treatment plan
Primary outcomes (1)
- measure
- PFS Progression Free Survival
- timeFrame
- 24 months
- description
- defined as non response after 4 or 6 cycles of chemotherapy or progression of disease after consolidation RT or at any time of therapy, relapse or death from any cause.
Secondary outcomes (1)
- measure
- OS Overall Survival
- timeFrame
- 48 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of DLBCL (CD20+), follicular lymphoma grade IIIB, T-cell rich large B cell lymphoma * Age 18-80 years (patients \>70 years old: FIT according to VGM evaluation). * aaIPI=1 +/- bulky and aaIPI=0 with bulky (\>7.5 cm) * ECOG-PS \< 3 unless due to lymphoma * Ventricular ejection fraction ≥ 50% * Pulmonary, renal and hepatic tests within normal range * Negative HIV and HBV tests. In case of HBcAb positive and HBsAb +/-, which is indicative of a past infection (occult carriers) the subject can be included, but antiviral prophylaxis with lamivudine must be given from the beginning of treatment until 12 months after treatment completion. Anti-HCV positive patients can be included in the absence of viral replication (HVR-RNA absent or less than 500 copies/ml. * Written informed consent * Life-expectancy \> 3 months Main Exclusion Criteria: * T-cell lymphoma * Follicular lymphoma (grade I, II, IIIA), marginal zone and mantle lymphoma * PS\> 3 (if not due to lymphoma) * Age-adjusted IPI = 0 in the absence of bulky disease * Age\> 80 and \<18 years (see inclusion criteria) * HIV positivity * significant cardiopathy
References
Publications (0)
Data not yet available
No reference posted for this study.