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This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT) as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each treatment cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegfilgrastim | Experimental | Participants will receive CT or ICT for 6 cycles on Days 1-6, as per standard of care. Protocol does not specify any choice of CT or ICT drugs. Participants will receive pegfilgrastim at a fixed dose of 6 mg subcutaneously, 24 hours after the last dose of CT or ICT in each treatment cycle. CT or ICT cycles of 21 days, as per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | The choice of CT will be as per standard of care and protocol does not specify any particular CT drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Febrile Neutropenia (Absolute Neutrophil Count [ANC] <0.5x10^9/L and Temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycle 1 | Cycle 1 (Up to 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Febrile Neutropenia (ANC <0.5x10^9/L and temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycles 2 to 6 | Cycles 2 to 6 (Up to 105 days) | |
| Percentage of Participants with Adverse Events | up to approximately 1.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bogotá | Colombia | |||||
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| Immunochemotherapy | Drug | The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug. |
|
| Pegfilgrastim | Drug | Pegfilgrastim will be administered at a fixed dose of 6 mg subcutaneously 24 hours after the last dose of CT or ICT is received for 6 cycles. |
|
|
| Chihuahua City |
| 31100 |
| Mexico |
| Chihuahua City | 31240 | Mexico |
| Estado de México | 52763 | Mexico |
| Guadalajara | 44139 | Mexico |
| León | 37320 | Mexico |
| León | 37520 | Mexico |
| Mexico City | 01120 | Mexico |
| Mexico City | 03100 | Mexico |
| Mexico City | 06770 | Mexico |
| Mexico City | 10700 | Mexico |
| Mexico City | 11520 | Mexico |
| Mexico City | 31000 | Mexico |
| Obregón | 85000 | Mexico |
| Puebla City | 72530 | Mexico |
| Querétaro | 76000 | Mexico |
| Tepic | 63120 | Mexico |
| Toluca | 52140 | Mexico |
| Veracruz | 91980 | Mexico |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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