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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Chemotherapy
Immunochemotherapy
Pegfilgrastim
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pegfilgrastim

Arm 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.

Outcomes

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

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
Percentage of Participants with Adverse Events

Full Information

First Posted
May 16, 2016
Last Updated
November 18, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02782845
Brief Title
An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)
Official Title
Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pegfilgrastim
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.
Intervention Type
Drug
Intervention Name(s)
Immunochemotherapy
Intervention Description
The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug.
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Neulastim
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
Percentage of Participants with Adverse Events
Time Frame
up to approximately 1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Bogota
Country
Colombia
City
Chihuahua
ZIP/Postal Code
31100
Country
Mexico
City
Chihuahua
ZIP/Postal Code
31240
Country
Mexico
City
Estado de Mexico
ZIP/Postal Code
52763
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44139
Country
Mexico
City
Leon
ZIP/Postal Code
37320
Country
Mexico
City
Leon
ZIP/Postal Code
37520
Country
Mexico
City
Mexico City
ZIP/Postal Code
01120
Country
Mexico
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
City
Mexico City
ZIP/Postal Code
06770
Country
Mexico
City
Mexico City
ZIP/Postal Code
10700
Country
Mexico
City
Mexico City
ZIP/Postal Code
11520
Country
Mexico
City
Mexico City
ZIP/Postal Code
31000
Country
Mexico
City
Obregon
ZIP/Postal Code
85000
Country
Mexico
City
Puebla
ZIP/Postal Code
72530
Country
Mexico
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
City
Tepic
ZIP/Postal Code
63120
Country
Mexico
City
Toluca
ZIP/Postal Code
52140
Country
Mexico
City
Veracruz
ZIP/Postal Code
91980
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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