MedDataX Logo

Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma

NCT ID: NCT00115193

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This was a multicenter, double-blind, randomized, phase 2 study of pegfilgrastim given either the same day as or the day after a chemotherapy regimen consisting of cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP).

Chemotherapy was administered every 21 days for up to 6 cycles in subjects with aggressive non-Hodgkin's lymphoma (NHL; mantle cell or diffuse large B-cell lymphoma). Subjects were administered R-CHOP on day 1 of each cycle. All subjects were randomized to 1 of 2 treatment arms: arm A subjects were administered pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion); arm B subjects were administered pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion). All subjects were administered placebo on the day they did not receive pegfilgrastim. A total of 77 subjects were enrolled at 24 centers across the US. Protocol treatment duration for subjects was up to 18 weeks (6 three-week cycles).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Hodgkin's Lymphoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Oncology NHL Mantle cell Diffuse large B-cell Chemotherapy RCHOP Neulasta® Neutropenia Pegfilgrastim Amgen

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

Pegfilgrastim

Group Type ACTIVE_COMPARATOR

pegfilgrastim

Intervention Type DRUG

pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)

Arm B

Pegfilgrastim

Group Type ACTIVE_COMPARATOR

pegfilgrastim

Intervention Type DRUG

pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pegfilgrastim

pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)

Intervention Type DRUG

pegfilgrastim

pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria: - Histologically proven mantle cell lymphoma or histologically proven diffuse large B-cell non-Hodgkin's lymphoma (NHL) according to the REAL classification - Measurable and/or evaluable disease - Previously untreated patients Exclusion Criteria: - Burkitt's or B-lymphoblastic lymphoma - Central nervous system (CNS) involvement - Active infection requiring treatment with systemic anti-infectives within 72 hours of chemotherapy - Prior malignancy within the last 5 years - T-cell lymphoma or history of indolent lymphoma - Prior bone marrow or stem cell transplantation - Known sensitivity to E. coli derived drug products
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MD

Role: STUDY_DIRECTOR

Amgen

Related Links

Access external resources that provide additional context or updates about the study.

http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_11_GCSFSD01_20020134.pdf

To access clinical trial results information click on this link

http://www.neulasta.com/

FDA-approved Drug Labeling

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20020134

Identifier Type: -

Identifier Source: org_study_id

NCT00066833

Identifier Type: -

Identifier Source: nct_alias