NCT02782845

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2006

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
Last Updated

November 21, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

May 16, 2016

Last Update Submit

November 18, 2016

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (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

    Cycle 1 (Up to 21 days)

Secondary Outcomes (2)

  • 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

Study Arms (1)

Pegfilgrastim

EXPERIMENTAL

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: ChemotherapyDrug: ImmunochemotherapyDrug: Pegfilgrastim

Interventions

ChemotherapyDRUG

The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.

Pegfilgrastim
ImmunochemotherapyDRUG

The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug.

Pegfilgrastim
PegfilgrastimDRUG

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.

Also known as: Neulastim
Pegfilgrastim

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Bogotá, Colombia

Location

Unknown Facility

Chihuahua City, 31100, Mexico

Location

Unknown Facility

Chihuahua City, 31240, Mexico

Location

Unknown Facility

Estado de México, 52763, Mexico

Location

Unknown Facility

Guadalajara, 44139, Mexico

Location

Unknown Facility

León, 37320, Mexico

Location

Unknown Facility

León, 37520, Mexico

Location

Unknown Facility

Mexico City, 01120, Mexico

Location

Unknown Facility

Mexico City, 03100, Mexico

Location

Unknown Facility

Mexico City, 06770, Mexico

Location

Unknown Facility

Mexico City, 10700, Mexico

Location

Unknown Facility

Mexico City, 11520, Mexico

Location

Unknown Facility

Mexico City, 31000, Mexico

Location

Unknown Facility

Obregón, 85000, Mexico

Location

Unknown Facility

Puebla City, 72530, Mexico

Location

Unknown Facility

Querétaro, 76000, Mexico

Location

Unknown Facility

Tepic, 63120, Mexico

Location

Unknown Facility

Toluca, 52140, Mexico

Location

Unknown Facility

Veracruz, 91980, Mexico

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Drug Therapypegfilgrastim

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 25, 2016

Study Start

June 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

November 21, 2016

Record last verified: 2016-09

Locations

CO(1)ME(18)