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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05338047

Enrollment

Registered

2022-04-20

Start date

2022-04-01

Completion date

2023-02-25

Last updated

2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Myeloma Multiple

Keywords

Autotransplant, Neutrophil recovery, Pegfilgrastim

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 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.

Interventions

DRUGPegfilgrastim

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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%)

Design outcomes

Primary

Measure	Time frame	Description
Time to neutrophil recovery	15 days	Time from autologous transplant to neutrophil count \>0.5x10\^3/microL

Secondary

Measure	Time frame	Description
Time to platelet recovery	15 days	Time from autologous transplant to platelet count \>20x10\^3/microL

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026