Status:
COMPLETED
Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Myeloma Multiple
Lymphoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.
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 gro...
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05338047
Start Date
April 1 2022
End Date
February 25 2023
Last Update
February 28 2023
Active Locations (1)
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1
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico, 66260