Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02782845
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Chemotherapy Drug: Immunochemotherapy Drug: Pegfilgrastim Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL)
Study Start Date : June 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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 Name: Neulastim




Primary Outcome Measures :
  1. 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 Measures :
  1. 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) ]
  2. Percentage of Participants with Adverse Events [ Time Frame: up to approximately 1.5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782845


Locations
Layout table for location information
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, 01120
Mexico City, Mexico, 03100
Mexico City, Mexico, 06770
Mexico City, Mexico, 10700
Mexico City, Mexico, 11520
Mexico City, Mexico, 31000
Obregon, Mexico, 85000
Puebla, Mexico, 72530
Queretaro, Mexico, 76000
Tepic, Mexico, 63120
Toluca, Mexico, 52140
Veracruz, Mexico, 91980
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Chair: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02782845     History of Changes
Other Study ID Numbers: ML19812
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases