Use of PEG-rHuMGDF in platelet engraftment after autologous stem cell transplantation

被引：7

作者：

Fields, KK

Crump, M

Bence-Bruckler, I

Bernstein, S

Williams, S

Frankel, S

Miller, A

Demetri, G

Nabholtz, JM

Cruickshank, S

Lill, M

机构：

[1] Univ S Florida, H Lee Moffitt Canc Ctr, Tampa, FL 33617 USA

[2] Toronto Hosp, Toronto, ON M5T 2S8, Canada

[3] Ottawa Gen Hosp, Ottawa, ON K1H 8L6, Canada

[4] Roswell Pk Canc Inst, Buffalo, NY 14263 USA

[5] Univ Chicago, Med Ctr, Chicago, IL 60637 USA

[6] Georgetown Univ, Med Ctr, Washington, DC 20007 USA

[7] Tulane Univ, Med Ctr, New Orleans, LA USA

[8] Dana Farber Canc Inst, Boston, MA 02115 USA

[9] Cross Canc Ctr, Edmonton, AB, Canada

[10] Amgen Inc, Thousand Oaks, CA 91320 USA

[11] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA

来源：

BONE MARROW TRANSPLANTATION | 2000年 / 26卷 / 10期

关键词：

PEG-rHuMGDF; platelet; engraftment; transplantation; clinical trial;

D O I：

10.1038/sj.bmt.1702662

中图分类号：

Q6 [生物物理学];

学科分类号：

071011 ;

摘要：

This paper summarizes a pilot, sequential dose-escalation study of PEG-rHuMGDF in patients with advanced malignancies who had delayed platelet recovery after autologous stem cell transplantation (ASCT), Patients were randomized to receive either placebo (n = 11) Or PEG-rHuMGDF at 5 (n = 9), 10 (n = 6), or 25 (n = 7) mug/kg/day by subcutaneous injection for 14 days and were monitored for 5 weeks. Across all treatment groups, eight patients had platelet recovery to greater than or equal to 20 x 10(9)/l by day 21, The proportion of patients achieving platelet recovery, the median number of days and units of platelet transfusions were similar for the placebo and the PEG-rHuMGDF groups. PEG-rHuMGDF was well tolerated at all dosages, The incidence rates of adverse events in all groups were similar. No deaths on study, no drug-related serious adverse events, and no development of neutralizing antibodies to MGDF occurred.

引用

页码：1083 / 1088

页数：6

共 21 条

[1] IDENTIFICATION AND CLONING OF A MEGAKARYOCYTE GROWTH AND DEVELOPMENT FACTOR THAT IS A LIGAND FOR THE CYTOKINE RECEPTOR MPL [J].

BARTLEY, TD ;

BOGENBERGER, J ;

HUNT, P ;

LI, YS ;

LU, HS ;

MARTIN, F ;

CHANG, MS ;

SAMAL, B ;

NICHOL, JL ;

SWIFT, S ;

JOHNSON, MJ ;

HSU, RY ;

PARKER, VP ;

SUGGS, S ;

SKRINE, JD ;

MEREWETHER, LA ;

CLOGSTON, C ;

HSU, E ;

HOKOM, MM ;

HORNKOHL, A ;

CHOI, E ;

PANGELINAN, M ;

SUN, Y ;

MAR, V ;

MCNINCH, J ;

SIMONET, L ;

JACOBSEN, F ;

XIE, C ;

SHUTTER, J ;

CHUTE, H ;

BASU, R ;

SELANDER, L ;

TROLLINGER, D ;

SIEU, L ;

PADILLA, D ;

TRAIL, G ;

ELLIOTT, G ;

IZUMI, R ;

COVEY, T ;

CROUSE, J ;

GARCIA, A ;

XU, W ;

DELCASTILLO, J ;

BIRON, J ;

COLE, S ;

HU, MCT ;

PACIFICI, R ;

PONTING, I ;

SARIS, C ;

WEN, D .

CELL, 1994, 77 (07) :1117-1124

[2] Thrombopoietic effects of pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) in patients with advanced cancer [J].

Basser, RL ;

Rasko, JEJ ;

Clarke, K ;

Cebon, J ;

Green, MD ;

Hussein, S ;

Alt, C ;

Menchaca, D ;

Tomita, D ;

Marty, J ;

Fox, RM ;

Begley, CG .

LANCET, 1996, 348 (9037) :1279-1281

[3]

Basser RL, 1997, BLOOD, V89, P3118

[4] FEBRILE REACTIONS AFTER PLATELET TRANSFUSION - THE EFFECT OF SINGLE VERSUS MULTIPLE DONORS [J].

CHAMBERS, LA ;

KRUSKALL, MS ;

PACINI, DG ;

DONOVAN, LM .

TRANSFUSION, 1990, 30 (03) :219-221

[5] STIMULATION OF MEGAKARYOCYTOPOIESIS AND THROMBOPOIESIS BY THE C-MPL LIGAND [J].

DESAUVAGE, FJ ;

HASS, PE ;

SPENCER, SD ;

MALLOY, BE ;

GURNEY, AL ;

SPENCER, SA ;

DARBONNE, WC ;

HENZEL, WJ ;

WONG, SC ;

KUANG, WJ ;

OLES, KJ ;

HULTGREN, B ;

SOLBERG, LA ;

GOEDDEL, DV ;

EATON, DL .

NATURE, 1994, 369 (6481) :533-538

[6] AUTOLOGOUS PROGENITOR-CELL TRANSPLANTATION - PRIOR EXPOSURE TO STEM CELL-TOXIC DRUGS DETERMINES YIELD AND ENGRAFTMENT OF PERIPHERAL-BLOOD PROGENITOR-CELL BUT NOT OF BONE-MARROW GRAFTS [J].

DREGER, P ;

KLOSS, M ;

PETERSEN, B ;

HAFERLACH, T ;

LOFFLER, H ;

LOEFFLER, M ;

SCHMITZ, N .

BLOOD, 1995, 86 (10) :3970-3978

[7] Effects of polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor on platelet counts after chemotherapy for lung cancer [J].

Fanucchi, M ;

Glaspy, J ;

Crawford, J ;

Garst, J ;

Figlin, R ;

Sheridan, W ;

Menchaca, D ;

Tomita, D ;

Ozer, H ;

Harker, L .

NEW ENGLAND JOURNAL OF MEDICINE, 1997, 336 (06) :404-409

[8] Regulation of platelet production and function by megakaryocyte growth and development factor in nonhuman primates [J].

Harker, LA ;

Hunt, P ;

Marzec, UM ;

Kelly, AB ;

Tomer, A ;

Hanson, SR ;

Stead, RB .

BLOOD, 1996, 87 (05) :1833-1844

[9]

Hassan H T, 1996, J Hematother, V5, P407, DOI 10.1089/scd.1.1996.5.407

[10] A PROSPECTIVE-STUDY TO IDENTIFY THE RISK-FACTORS ASSOCIATED WITH ACUTE REACTIONS TO PLATELET AND RED-CELL TRANSFUSIONS [J].

HEDDLE, NM ;

KLAMA, LN ;

GRIFFITH, L ;

ROBERTS, R ;

SHUKLA, G ;

KELTON, JG .

TRANSFUSION, 1993, 33 (10) :794-797

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