An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)
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| ClinicalTrials.gov Identifier: NCT02782845 |
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Recruitment Status :
Completed
First Posted : May 25, 2016
Last Update Posted : November 21, 2016
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Hodgkin's Lymphoma | Drug: Chemotherapy Drug: Immunochemotherapy Drug: Pegfilgrastim | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 53 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL) |
| Study Start Date : | June 2006 |
| Actual Primary Completion Date : | October 2007 |
| Actual Study Completion Date : | October 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Pegfilgrastim
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pegfilgrastim
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.
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Drug: Chemotherapy
The choice of CT will be as per standard of care and protocol does not specify any particular CT drug. Drug: Immunochemotherapy The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug. Drug: Pegfilgrastim 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.
Other Name: Neulastim |
Primary Outcome Measures :
- 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 [ Time Frame: Cycle 1 (Up to 21 days) ]
Secondary Outcome Measures :
- 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 [ Time Frame: Cycles 2 to 6 (Up to 105 days) ]
- Percentage of Participants with Adverse Events [ Time Frame: up to approximately 1.5 years ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- NHL supported by an Immunohistochemical report
- Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to (>/=) 2
- Total serum bilirubin less than (<) 2 times upper limit of normal (ULN)
- Absolute neutrophil count (ANC) greater than (>) 2 x10^9 per liter (/L)
Exclusion Criteria:
- Bone marrow compromised > 10 percent (%)
- Any malignant myeloid condition
- Active infections requiring systemic anti-infectious therapies (antibiotics, antifungal drugs, antiviral drugs) within 72 hours prior to CT or ICT initiation
- Known hypersensitivity reactions to Escherichia coli derived products
- Pregnant or nursing participants. Women with childbearing potential should use a safe contraceptive method
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782845
Locations
| Colombia | |
| Bogota, Colombia | |
| Mexico | |
| Chihuahua, Mexico, 31100 | |
| Chihuahua, Mexico, 31240 | |
| Estado de Mexico, Mexico, 52763 | |
| Guadalajara, Mexico, 44139 | |
| Leon, Mexico, 37320 | |
| Leon, Mexico, 37520 | |
| Mexico City, Mexico, 01120 | |
| Mexico City, Mexico, 03100 | |
| Mexico City, Mexico, 06770 | |
| Mexico City, Mexico, 10700 | |
| Mexico City, Mexico, 11520 | |
| Mexico City, Mexico, 31000 | |
| Obregon, Mexico, 85000 | |
| Puebla, Mexico, 72530 | |
| Queretaro, Mexico, 76000 | |
| Tepic, Mexico, 63120 | |
| Toluca, Mexico, 52140 | |
| Veracruz, Mexico, 91980 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Chair: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT02782845 |
| Other Study ID Numbers: |
ML19812 |
| First Posted: | May 25, 2016 Key Record Dates |
| Last Update Posted: | November 21, 2016 |
| Last Verified: | September 2016 |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |