Clincosm LogoSign in Get a demo

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

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez (Other)
Overall Status
Recruiting
CT.gov ID
NCT05338047
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 (>0.5x103/microL) and platelet recovery (>20x103/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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilgrastim for Neutrophil Recovery After Autologous Stem Cell Transplant
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to neutrophil recovery [15 days]

      Time from autologous transplant to neutrophil count >0.5x10^3/microL

    Secondary Outcome Measures

    1. Time to platelet recovery [15 days]

      Time from autologous transplant to platelet count >20x10^3/microL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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%)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario Dr. José Eleuterio González Monterrey Nuevo León Mexico 66260

    Sponsors and Collaborators

    • Hospital Universitario Dr. Jose E. Gonzalez

    Investigators

    • Principal Investigator: Cesar H Gutierrez Aguirre, Hospital Universitario

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cesar Homero Gutierrez-Aguirre, Clinical Professor, Hospital Universitario Dr. Jose E. Gonzalez
    ClinicalTrials.gov Identifier:
    NCT05338047
    Other Study ID Numbers:
    • HE22-00006
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Cesar Homero Gutierrez-Aguirre, Clinical Professor, Hospital Universitario Dr. Jose E. Gonzalez
    Autotransplant
    Neutrophil recovery
    Pegfilgrastim
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Apr 20, 2022