An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)

Study Overview
=================
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.

Official Title
-----------------
Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL)

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: Chemotherapy
* Drug: Immunochemotherapy
* Drug: Pegfilgrastim


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegfilgrastim<br>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. | Drug: Chemotherapy<br>* The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.<br>Drug: Immunochemotherapy<br>* The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug.<br>Drug: Pegfilgrastim<br>* 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.<br>* Other names: Neulastim;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |