Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant
NCT ID: NCT05338047
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2022-04-01
2023-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Generic pegfilgrastim
One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant
Pegfilgrastim
Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
Brand name pegfilgrastim
One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant
Pegfilgrastim
Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
Interventions
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Pegfilgrastim
Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with multiple myeloma or lymphoma
* Adults (\>18 years)
* Both genders
* Eastern Cooperative Oncology Group (ECOG) \<=2
Exclusion Criteria
* Creatinin \>2.2mg/dL
* Fever \>37.6°C
* Active infection
* Hepatitis B, C or HIV infection
* Congestive heart failure (ejection fraction \<40%)
18 Years
90 Years
ALL
No
Sponsors
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Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
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Cesar Homero Gutierrez-Aguirre
Clinical Professor
Principal Investigators
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Cesar H Gutierrez Aguirre
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario
Locations
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Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico
Countries
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References
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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.
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.
Other Identifiers
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HE22-00006
Identifier Type: -
Identifier Source: org_study_id
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