NCT05338047

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

April 1, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

April 12, 2022

Last Update Submit

February 25, 2023

Conditions

Myeloma MultipleLymphoma

Keywords

AutotransplantNeutrophil recoveryPegfilgrastim

Outcome Measures

Primary Outcomes (1)

  • Time to neutrophil recovery

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

    15 days

Secondary Outcomes (1)

  • Time to platelet recovery

    15 days

Study Arms (2)

Generic pegfilgrastim

PLACEBO COMPARATOR

One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant

Drug: Pegfilgrastim

Brand name pegfilgrastim

ACTIVE COMPARATOR

One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant

Drug: Pegfilgrastim

Interventions

PegfilgrastimDRUG

Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.

Also known as: Neulasta, Linkix
Brand name pegfilgrastimGeneric pegfilgrastim

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 66260, Mexico

Location

Related Publications (2)

  • Jagasia MH, Greer JP, Morgan DS, Mineishi S, Kassim AA, Ruffner KL, Chen H, Schuening FG. Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study. Bone Marrow Transplant. 2005 Jun;35(12):1165-9. doi: 10.1038/sj.bmt.1704994.

    PMID: 15880129RESULT

  • Sheth V, Gore A, Jain R, Ghanekar A, Saikia T. Pegfilgrastim: More Cost Effective and Equally Efficacious Option as Compared to Filgrastim in Autologous Stem Cell Transplant. Indian J Hematol Blood Transfus. 2019 Jan;35(1):66-71. doi: 10.1007/s12288-018-0966-5. Epub 2018 May 17.

    PMID: 30828150RESULT

MeSH Terms

Conditions

Multiple MyelomaLymphoma

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphatic Diseases

Study Officials

  • Cesar H Gutierrez Aguirre

    Hospital Universitario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 20, 2022

Study Start

April 1, 2022

Primary Completion

February 25, 2023

Study Completion

February 25, 2023

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)