Clinical trial · Interventional
Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma
Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients
NCT01009970CI-TRIAL-00005624unknownPhase 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)
This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- R-COMP
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Prednisone
- Drug: Doxorubicin
Primary outcomes (1)
- measure
- Feasibility of R-COMP in cardiopathic patients
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Response rates
- timeFrame
- 1 year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
Show eligibility criteria text
Inclusion Criteria: * NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL; * Age \>= 18 years; * Presence of at least 1 factor that defines the cardiopathy; * Life expectancy \> 3 months; * In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy; * Written informed consent. Exclusion Criteria: * Histology different from NHL diffuse large cell CD20 + or follicular IIIb * Age \< 18 years * Inability to sign informed consent; * HIV positivity; * Patients HBsAg positive; * AST/ALT \> 2 times the standard; * Bilirubin \> 2 times the standard; * Creatinine \> 2.5 mg / dl; * Location of CNS disease; * Pregnancy ongoing; * Damage to that organ or medical problems that could interfere with the therapy; * Current uncontrolled infection; * Senile dementia
References
Publications (0)
Data not yet available
No reference posted for this study.