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| Name | Class |
|---|---|
| Cephalon | INDUSTRY |
| Pivotal S.L. | INDUSTRY |
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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
Phase II, multicenter, open , 1-arm study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unique | Experimental | RCOMP-14 with Rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RCOMP-14 + rituximab | Drug | Pretreatment: vincristine 1mg at day -6 and Methylprednisolone 100 mg from -6 to day 0. Treatment: rituximab 375m/m2 + ciclophosphamide 750 mg/m2 + Vincristine 1.4 mg/m2 + Doxorrubicine 50 mg/m2 at day 1 and every 14d. Prednisone 100 mg/d from day 1 to 5 and every 14 d. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate treatment efficacy by measuring response to treatment | at the end of study |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate cardiotoxicity and tolerability | At the end of study | |
| Evaluate progression free survival | At the end of study | |
| Evaluate event free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Secundino Ferrer | Contact | +34961622536 | ferrer_sec@gva.es | |
| Felix Carbonell | Contact | +34961972000 | carbonell_fel@gav.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hospital del Mar | Active, not recruiting | Barcelona | 08003 | Spain | ||
| Hospital Vall D'Hebrón |
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|
| At the end of study |
| Evaluate tumor free survival | At the end of study |
| Evaluate overall survival | At the end of study |
| Evaluate response duration | At the end of study |
| treatment adherence | At the end of study |
| time to progression | At the end of the study |
| dose intensity and relative dose intensity | At the end of the study |
| Active, not recruiting |
| Barcelona |
| 08035 |
| Spain |
| Hospital de Castellon | Active, not recruiting | Castellon | 12004 | Spain |
| Hospital Severo Ochoa | Not yet recruiting | Madrid | 28211 | Spain |
|
| Hospital Universitario Puerta de Hierro | Active, not recruiting | Madrid | 28220 | Spain |
| Hospital de Getafe | Recruiting | Madrid | Spain |
|
| Hospital son Llatzer | Active, not recruiting | Mallorca | 07198 | Spain |
| Hospital Morales Messeguer | Not yet recruiting | Murcia | 30008 | Spain |
|
| Hospital Santa Mª del Rosell | Not yet recruiting | Murcia | 30203 | Spain |
|
| Hospital general universitario de Valencia | Active, not recruiting | Valencia | 46014 | Spain |
| H. Arnau de Vilanova | Active, not recruiting | Valencia | 46015 | Spain |
| Hospital Universitario Dr. Peset | Active, not recruiting | Valencia | 46017 | Spain |
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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