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Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

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Amgen

Status and phase

Completed
Phase 2

Conditions

Sarcoma
Neutropenia

Treatments

Drug: pegfilgrastim
Drug: filgrastim

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.

Enrollment

44 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Filgrastim
Active Comparator group
Description:
Filgrastim
Treatment:
Drug: filgrastim
Pegfilgrastim
Experimental group
Description:
Pegfilgrastim
Treatment:
Drug: pegfilgrastim

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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