Clinical trial · Interventional
Ciclophosphamide, Vincristine, Myocet and Prednisone, With Rituximab in 1st-Line Treatment for Patients With No-Hodgkin B Lymphoma and Cardiovascular (CV) Risk
Phase II, Multicenter Trial to Evaluate the Efficacy and Safety of the Following Treatment Squeme:Ciclophosphamide, Vincristine, Lyposomal Doxorrubicine, Myocet and Prednisone,Combined With Rituximab in First Line Treatment for Patients With Aggresive No Hodgkin B Lymphoma and Cardiovascular Risk
- 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 purpose of this study is to evaluate the efficacy (and safety) of the following treatment squeme:Ciclophosphamide, Vincristine, lyposomal Doxorrubicine (Myocet) and Prednisone,combined with Rituximab in first line treatment for patients with aggresive No Hodgkin B lymphoma and cardiovascular risk
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 |
|---|---|---|---|
| No Hodgkin B Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RCOMP-14 + rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- unique
- description
- RCOMP-14 with Rituximab
- interventionNames
- Drug: RCOMP-14 + rituximab
Primary outcomes (1)
- measure
- Evaluate treatment efficacy by measuring response to treatment
- timeFrame
- at the end of study
Secondary outcomes (9)
- measure
- evaluate cardiotoxicity and tolerability
- timeFrame
- At the end of study
- measure
- Evaluate progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histological diagnosis of Lymphoma no Hodgkin B CD20+ high degree of mailgnancy 2. Patients no previously treated 3. stage III o IV 4. Informed consent 5. At least one measurable injury 6. Age \>18 7. ECOG 0-2 8. Life expectancy \>6 months 9. Cardiovascular risk defined as:Mild-moderate systolic dysfunction,isquemic cardiopathy, diabetes mellitus, hypertension,left ventricular hypertrophy, cardiac arrhythmia, moderate pulmonar hypertension 10. adequate organic functionallity (creatinine\<2mg/dl;bilirubin\<2mg/dl; ALT-AST-FA\<5 FSN; neutrphyls total count \>1.5x 109/l and platellet count \>100x1097l) 11. Use of a contraceptive method during study + 3 months - Exclusion Criteria: 1. stage I or II with IPI=0 2. Symptomatic tumoral affection of Nervous central system 3. Lymphoma no hodgkin B indolent 4. Lymphoma no hodgkin B mantle-cell 5. Lymphoma no hodgkin T 6. lymphoprolifertaive syndrome post-transplantation or immunosuppression associated 7. cardiovacualr disease symptomatic 8. Cronic infection or acute serious 9. history of neoplasia in past 5 years 10. not able to understand the study or poor protocol adherence 11. Known Hypersensivity to any atudy drug 12. pregnant/lactant women 13. Previous participation in clinicla study in past 30 days 14. Previous treatment with antraciclines or any drug used in this study
References
Publications (0)
Data not yet available