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| ID | Type | Description | Link |
|---|---|---|---|
| PRO1908TREND | Other Identifier | PRO1908TREND012011 |
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This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously untreated patients with diffuse B cells Non Hodgkin lymphoma.
At present R-CHOP (Rituximab plus Cyclofosfamide, Doxorrubicine, Vincristine and Prednisone) has became standard of care of patients with B cells Non Hodgkin Lymphoma CD20+.
Study will perform pharmacodynamic (PD) and pharmacokinetic (PK) measurment of a novel Rituximab in comparison with Mabthera and evaluates safety both metabolic as well immunologic.
Study protocolo is designed to provide data on impact of treatment interchange of both study drugs (PBO-326 and Mabthera).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 / PBO-326 | Experimental | This group will be treated three cycles with PBO-326, after the third cycle the patients will receive Mabthera for another three cycles. |
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| Group 2 / Mabthera | Active Comparator | This group will be treated three cycles with Mabthera, after the third cycle the patients will receive PBO-326 for another three cycles. |
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| Group 3 / PBO-326 | Experimental | This group will be treated six cycles with PBO-326 |
|
| Group 4 / Mabthera | Active Comparator | This group will be treated six cycles with Mabthera |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Biological | 375 mg/m2 IV every 2 weeks for 6 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Basal and final serum CD 20 levels comparison. | Primary outcome is the depletion of CD20+ B cells. This will be measured every 14 days and comparison will be made basal levels versus visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and visit 8. | Every 14 days for the duration of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of safety of PBO-326 versus Mabthera | Adverse events will be observed and recorded in relation to acute infusion events (number of cases and severity of hypotension, hipertension, headache, and all cardiovascular events previously reported by Mabthera) as well as long term effects over key hematological cells (number of cases and severity of neutropenia, trombocytopenia, leucopenia) per visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge Revilla Beltri, MD | Contact | (00+1) 55 25811969 | jorge.revilla@probiomed.com.mx | |
| Aaron Molina Perez, MD | Contact | (00+1) 55 25811924 | ignacio.molina@probiomed.com.mx |
| Name | Affiliation | Role |
|---|---|---|
| Jorge Revilla Beltri, MD | Probiomed S.A. de C.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INCan | Recruiting | México | D.f. | 14080 | Mexico |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D007160 | Immunoproliferative Disorders |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Rituximab | Biological | 375 mg/m2 IV every 2 weeks for 6 cycles |
|
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| Rituximab | Biological | 375 mg/m2 IV every 2 weeks for 6 cycles |
|
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| Rituximab | Biological | 375 mg/m2 IV every 14 days for 6 cycles |
|
|
| Every 14 days measurements |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |