Clinical trial · Interventional
An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)
Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL)
NCT02782845CI-TRIAL-00024858completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Immunochemotherapy | Drug | — | UNRESOLVED |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pegfilgrastim
- description
- 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.
- interventionNames
- Drug: Chemotherapy
- Drug: Immunochemotherapy
- Drug: Pegfilgrastim
Primary outcomes (1)
- measure
- 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
- timeFrame
- Cycle 1 (Up to 21 days)
Secondary outcomes (2)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.