- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05338047
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
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 Contact
- Name: Cesar H Gutierrez Aguirre, PhD
- Phone Number: 81 8348 6136
- Email: hematohu@yahoo.com
Study Contact Backup
- Name: Fernando De la Garza Salazar, MD
- Phone Number: 81 8348 6136
- Email: fernandodelagarza@gmail.com
Study Locations
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico, 66260
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
-
-
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
|
Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
Other Names:
|
Active Comparator: Brand name pegfilgrastim
One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant
|
Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
Other Names:
|
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.
Investigators
- Principal Investigator: Cesar H Gutierrez Aguirre, Hospital Universitario
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
- 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.
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
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
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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