Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant

February 25, 2023 updated by: Cesar Homero Gutierrez-Aguirre, Hospital Universitario Dr. Jose E. Gonzalez

Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilgrastim for Neutrophil Recovery After Autologous Stem Cell Transplant

This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty consecutive adults with lymphoma or myeloma receiving autologous peripheral blood stem cell transplant will be included in this phase 2 clinical trial. Patients will be allocated 1:1 in two groups: one subcutaneous 6 mg dose of generic pegfilgrastim (control group) or one 6mg dose of brand-name pegfilgrastim (intervention group) both at day +1 after the autotransplant. Daily complete blood counts were collected and time to neutrophil (>0.5x10^3/microL) and platelet recovery (>20x10^3/microL) will be obtained. The investigators will describe the proportion of adverse events and median time to neutrophil and platelet recoveries. Median or mean time to neutrophil recovery and time to platelet recovery will be calculated and compared with Mann-Whitney-Wilcoxon test or student T.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

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

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66260
        • Hospital Universitario Dr. Jose Eleuterio González

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing autologous peripheral blood stem cell transplantation
  • Patients with multiple myeloma or lymphoma
  • Adults (>18 years)
  • Both genders
  • Eastern Cooperative Oncology Group (ECOG) <=2

Exclusion Criteria:

  • Alanine Aminotransferase or bilirubin values >2.5 times the superior normal limit
  • Creatinin >2.2mg/dL
  • Fever >37.6°C
  • Active infection
  • Hepatitis B, C or HIV infection
  • Congestive heart failure (ejection fraction <40%)

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Generic pegfilgrastim
One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant
Drug: Pegfilgrastim
Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
Other Names:
  • Neulasta
  • Linkix
Active Comparator: Brand name pegfilgrastim
One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant
Drug: Pegfilgrastim
Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
Other Names:
  • Neulasta
  • Linkix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to neutrophil recovery
Time Frame: 15 days
Time from autologous transplant to neutrophil count >0.5x10^3/microL
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to platelet recovery
Time Frame: 15 days
Time from autologous transplant to platelet count >20x10^3/microL
15 days

Collaborators and Investigators

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

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Principal Investigator: Cesar H Gutierrez Aguirre, Hospital Universitário

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 1, 2022

Primary Completion (Actual)

February 25, 2023

Study Completion (Actual)

February 25, 2023

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 25, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE22-00006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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