An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)
NCT ID: NCT02782845
Last Updated: 2016-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
53 participants
INTERVENTIONAL
2006-06-30
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Chemotherapy
The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.
Immunochemotherapy
The choice of ICT will be as per standard of care and protocol does not specify any particular ICT 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.
Interventions
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Chemotherapy
The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.
Immunochemotherapy
The choice of ICT will be as per standard of care and protocol does not specify any particular ICT 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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Bogotá, , Colombia
Chihuahua City, , Mexico
Chihuahua City, , Mexico
Estado de México, , Mexico
Guadalajara, , Mexico
León, , Mexico
León, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Obregón, , Mexico
Puebla City, , Mexico
Querétaro, , Mexico
Tepic, , Mexico
Toluca, , Mexico
Veracruz, , Mexico
Countries
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Other Identifiers
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ML19812
Identifier Type: -
Identifier Source: org_study_id