Non-Hodgkin Lymphoma
Conditions
Keywords
stem cell transplantation, stem cell mobilization, high-dose therapy
Brief summary
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
Detailed 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).
Interventions
DRUGpegfilgrastim
Single dose (6mg) one day after chemotherapy
Sponsors
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematopoietic recovery after autologous stem cell transplantation | 1-3 weeks after transplantation, follow up every 3 months (up to 2 years) | Two cycles of conventional chemotherapy are given. Starting one day after the first cycle, filgrastim (5ug/kg bodyweight daily subcutaneously) is routinely administered to support neutrophil recovery. One day after the second cycle, a single dose of pegfilgrastim (6mg) is given to support neutrophil recovery and stem cell collection. Hematopoietic recovery (blood count) is monitored daily after high-dose therapy and autologous stem cell transplantation. Follow up assessments are performed 3-monthly for late graft failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraindividual comparison of quantity/quality of circulating stem cells | before and during 3 weeks after conventional chemotherapy | Circulating stem cells are enumerated by flow cytometry and colony assays during filgrastim (intraindividual control) and pegfilgrastim-supported recovery from chemotherapy. |
Countries
Germany
Outcome results
None listed