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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338047
• Other study ID #: HE22-00006
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2022
• Est. completion date: February 25, 2023

Study information

• Verified date: February 2023
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 25, 2023
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Myeloma Multiple
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Universitario Dr. José Eleuterio González	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & 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: — View Citation

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/s12288-018-0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to neutrophil recovery	Time from autologous transplant to neutrophil count >0.5x10^3/microL	15 days
Secondary	Time to platelet recovery	Time from autologous transplant to platelet count >20x10^3/microL	15 days