Pegfilgrastim vs. Filgrastim - Comparison of Mobilized Blood Stem Cells in Patients With Non Hodgkin-lymphoma

University Hospital Tuebingen

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin Lymphoma

Treatments: Drug: pegfilgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT00306111

rpm_001

Details and patient eligibility

About

The purpose of this study is to compare the ability of pegfilgrastim vs. filgrastim to mobilize peripheral blood stem cells in patients with Non Hodgkin-lymphoma in an intraindividual study

Full description

Patients with Non Hodgkin-lymphoma undergoing stem cell mobilization for planned high-dose therapy will be treated with two cycles of chemotherapy (etoposide, ifosfamide, cisplatin, epirubicin), either followed by daily administration of filgrastim (first cycle) or pegfilgrastim (once after the second cycle). The number of circulating cluster of differentiation 34+ cells, colony-forming units and primitive progenitors will be analyzed at corresponding time points. Peripheral blood stem cells will be collected after the second cycle of chemotherapy by leukapheresis. After the second cycle, high-dose therapy with peripheral blood stem cell support will be administered (the protocol will be chosen according to the diagnosis, including total body irradiation-containing regimens).

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histological diagnosis of non-Hodgkin lymphoma
• planned high-dose therapy with autologous stem cell transplantation
• WHO performance status 0-2
• written consent

Exclusion criteria

• allergy against (peg)filgrastim
• life expectancy <3 months
• other malignant diseases within the last 5 years
• cardial insufficiency (>= New York Heart Association II°)
• uncontrolled infection
• pregnancy, lactation
• central nervous system lymphoma
• Karnofsky score <70%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Pegfilgrastim

Experimental group

Description:

Pegfilgrastim for stem cell mobilization (single arm)

Treatment:

Drug: pegfilgrastim