A phase 2 pilot study of pegfilgrastim and filgrastim for mobilizing peripheral blood progenitor cells in patients with non-Hodgkin's lymphoma receiving chemotherapy

Haematologica

Volumn 93, Issue 3, 2008, Pages 405-412

  Russell, Nigel ^a   Mesters, Rolf ^b   Schubert, Joerg ^c   Boogaerts, Marc ^d   Johnsen, Hans E ^e   Del Canizo, Consuelo ^f   Baker, Nigel ^g   Barker, Philippa ^g   Skacel, Tomas ^h   Schmitz, Norbert ⁱ  

^a NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

^b UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^c SAARLAND UNIVERSITY   (Germany)

^d UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^e AALBORG UNIVERSITY HOSPITAL   (Denmark)

^f HOSPITAL UNIVERSITARIO DE SALAMANCA   (Spain)

^g AMGEN LTD   (United Kingdom)

^h AMGEN INC   (United States)

ⁱ DEPARTMENT OF CARDIOLOGY   (Germany)

Author keywords

Filgrastim; Mobilization; Non Hodgkin's lymphoma; Pegfilgrastim; Peripheral blood progenitor cell transplantation

Indexed keywords

CARBOPLATIN; CARMUSTINE; CYTARABINE; ETOPOSIDE; IFOSFAMIDE; MELPHALAN; PLACEBO; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

AGED; ANEMIA; ARTHRALGIA; ARTICLE; BACKACHE; BONE PAIN; CANCER CHEMOTHERAPY; CANCER PATIENT; CD34 SELECTION; CELL MOTILITY; CELL TRANSPLANTATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROLYTE DISTURBANCE; FEMALE; FOLLOW UP; HEADACHE; HUMAN; LEUKAPHERESIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIC SEPSIS; NONHODGKIN LYMPHOMA; PERIPHERAL BLOOD STEM CELL; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SINGLE DRUG DOSE; THROMBOCYTOPENIA; TREATMENT RESPONSE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BLOOD CELL COUNT; CARBOPLATIN; CARMUSTINE; CYTARABINE; DOUBLE-BLIND METHOD; ETOPOSIDE; FEMALE; FILGRASTIM; HEMATOPOIETIC STEM CELL MOBILIZATION; HUMANS; IFOSFAMIDE; LYMPHOMA, NON-HODGKIN; MALE; MELPHALAN; MIDDLE AGED; PERIPHERAL BLOOD STEM CELL TRANSPLANTATION; TRANSPLANTATION, AUTOLOGOUS;

EID: 40849098151     PISSN: 03906078     EISSN: None     Source Type: Journal    
DOI: 10.3324/haematol.11287     Document Type: Article

References (18)

1. Korbling M, Champlin R. Peripheral blood progenitor cell transplantation: a replacement for marrow auto- or allografts. Stem Cells 1996;14:185-95.
2. Molineux G. The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta). Curr Pharm Des 2004;10:1235-44.
3. Holmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, et al. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol 2002;13:903-9.
4. Johnston E, Crawford J, Blackwell S, Bjurstrom T, Lockbaum P, Roskos L, et al. Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol 2000; 18:2522-8.
5. George S, Yunus F, Case D, Yang BB, Hackett J, Shogan JE, et al. Fixed-dose pegfilgrastim is safe and allows neutrophil recovery in patients with non-Hodgkin's lymphoma. Leuk Lymphoma 2003;44:1691-6.
6. Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol 2003;14:29-35.
7. Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol 2002; 20:727-31.
8. Isidorins A, Tani M, Bonifazi F, Zinzani P, Curti A, Motta MR, et al. Phase II study of a single pegfilgrastim injection as an adjunct to chemotherapy to mobilize stem cells into the peripheral blood of pretreated lymphoma patients. Haematologica 2005;90:225-31.
9. Steidl U, Fenk R, Bruns I, Neumann F, Kondakci M, Hoyer B, et al. Successful transplantation of peripheral blood stem cells mobilized by chemotherapy and a single dose of pegylated G-CSF in patients with multiple myeloma. Bone Marrow Transplant 2005;35:33-6.
10. Kroschinsky F, Holig K, Poppe-Thiede K, Zimmer K, Ordemann R, Blechschmidt M, et al. Single-dose pegfilgrastim for the mobilization of allogeneic CD34+ peripheral blood progenitor cells in healthy family and unrelated donors. Haematologica 2005;90:1665-71.
11. Kewalramani T, Zelenetz AD, Nimer SD, Portlock C, Straus D, Noy A, et al. Rituximab and ICE as second-line therapy before autologous stem cell transplantation for relapsed or primary refractory diffuse large B-cell lymphoma. Blood 2004;103:3684-8.
12. Kroschinsky F, Hoelig K, Platzbecker U, Schleyer E, Ordemann R, Haack A, et al. Single-dose pegfilgrastim after chemotherapy is highly effective in enhancing the mobilization of autologous CD34+ peripheral blood stem cells in patients with lymphoid malignancies and solid tumors. Blood 2004;104:Abstract 2922.
13. Bruns I, Steidl U, Kronenwett R, Fenk R, Graef T, Rohr UP, et al. A single dose of 6 or 12 mg of pegfilgrastim for peripheral blood progenitor cell mobilization results in similar yields of CD34+ progenitors in patients with multiple myeloma. Transfusion 2006;46:180-5.
14. Molineux G, Kinstler O, Briddell B, Hartley C, McElroy P, Kerzic P, et al. A new form of filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans. Exp Hematol 1999;27: 1724-34.
15. Willis F, Pettengell R, Woll P, Desborough C, Buchanan K. Pegfilgrastim alone successfully mobilizes CD34+ cells in chemotherapy-naive subjects with solid tumors: initial results of a phase 1-2 study (abstract no 2687). Blood 2004;12.
16. Martin-Murea S, Voso MT, Hohaus S, Pforsich M, Fruehauf S, Goldschmidt H, et al. The dose of granulocyte colony-stimulating factor administered following cytotoxic chemotherapy is not related to the rebound level of circulating CD34+ haemopoietic progenitor cells during marrow recovery. Br J Haematol 1998;101:582-5.
17. Grigg A, Solal-Celigny P, Hoskin P, Taylor K, McMillan A, Forstpointner R, et al. Open-label, randomized study of pegfilgrastim vs. daily filgrastim as an adjunct to chemotherapy in elderly patients with non-Hodgkin's lymphoma. Leuk Lymphoma 2003;44:1503-8.
18. Vose JM, Crump M, Lazarus H, Emm anouilides C, Schenkein D, Moore J, et al. Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma J Clin Oncol 2003;21:514-9.