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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782845
• Other study ID #: ML19812
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2016
• Last updated: November 18, 2016
• Start date: June 2006
• Est. completion date: October 2007

Study information

• Verified date: September 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	Percentage of Participants with Adverse Events		up to approximately 1.5 years	No