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

November 18, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia
  • Mexico
      • Chihuahua, Mexico, 31100
      • Chihuahua, Mexico, 31240
      • Estado de Mexico, Mexico, 52763
      • Guadalajara, Mexico, 44139
      • Leon, Mexico, 37320
      • Leon, Mexico, 37520
      • Mexico City, Mexico, 03100
      • Mexico City, Mexico, 10700
      • Mexico City, Mexico, 11520
      • Mexico City, Mexico, 01120
      • Mexico City, Mexico, 06770
      • Mexico City, Mexico, 31000
      • Obregon, Mexico, 85000
      • Puebla, Mexico, 72530
      • Queretaro, Mexico, 76000
      • Tepic, Mexico, 63120
      • Toluca, Mexico, 52140
      • Veracruz, Mexico, 91980

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Chemotherapy
The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.
Drug: Immunochemotherapy
The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug.
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 Names:
  • Neulastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Cycle 1 (Up to 21 days)
Cycle 1 (Up to 21 days)

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Cycles 2 to 6 (Up to 105 days)
Cycles 2 to 6 (Up to 105 days)
Percentage of Participants with Adverse Events
Time Frame: up to approximately 1.5 years
up to approximately 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 25, 2016

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML19812

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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