Transplantation of Peripheral Blood Progenitor Cells (PBPCs)
Leukine® (sargramostim) is indicated for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis. Mobilization allows for the collection of increased numbers of progenitor cells capable of engraftment as compared with collection without mobilization. After myeloablative chemotherapy, the transplantation of an increased number of progenitor cells can lead to more rapid engraftment, which may result in a decreased need for supportive care. Myeloid reconstitution is further accelerated by administration of Leukine following peripheral blood progenitor cell transplantation.
A retrospective review was conducted of data from patients with cancer undergoing collection of peripheral blood progenitor cells (PBPC) at a single transplant center. Mobilization of PBPC and myeloid reconstitution post-transplant were compared between four groups of patients (n=196) receiving Leukine for mobilization and a historical control group who did not receive any mobilization treatment [progenitor cells collected by leukapheresis without mobilization (n=100)]. The cohorts differed by dose (125 or 250 mcg/m2/day), route (IV over 24 hours or SC) and use of Leukine post-transplant.
Leukine was effective for mobilization of PBPCs before and during leukapheresis of cells for transplantation. Leukine increased the number of progenitor cells and myeloid recovery after PBPC transplantation. Leukine decreased days to neutrophil recovery, days to last red blood cell (RBC) transfusion, days to last platelet transfusion, days to engraftment, and days of hospitalization. Leukine did not adversely affect relapse rate or survival. The detailed results are provided below.
ANC and Platelet Recovery After PBPC Transplant1
(Median Value in Days)
|ANC > 500/mm3||Last Platelet Transfusion|
The most marked mobilization and post-transplant effects were seen in patients administered the higher dose of Leukine1:
- Mobilized patients had fewer days to the last platelet transfusion and last RBC transfusion, and a shorter duration of hospitalization, than did non-mobilized patients
- Liquid solutions containing benzyl alcohol (including liquid Leukine) or lyophilized Leukine reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates
|Percent of AuBMT Patients Reporting Events|
|Events by Body System||LEUKINE (n=79)||Placebo (n=77)||Events by Body System||LEUKINE (n=79)||Placebo (n=77)|
|Body, General||Metabolic, Nutritional Disorder|
|Mucous membrane disorder||75||78||Peripheral edema||11||7|
|Digestive System||Hemic and Lymphatic System|
|GI disorder||37||47||Urinary tract disorder||14||13|
|GI hemorrhage||27||33||Kidney function abnormal||8||10|
|Liver damage||13||14||CNS disorder||11||16|
|Skin and Appendages|
- LEUKINE® (sargramostim) [package insert]. Genzyme Corporation 2009.
- Rowe JM, Rubin A, Mazza JJ, et al. Incidence of infections in adult patients (> 55 years) with acute myeloid leukemia treated with yeast-derived GM-CSF (sargramostim): results of a double-blind prospective study by the Eastern Cooperative Oncology Group. In: Hiddemann W, et al, eds. Acute Leukemias V: Experimental Approaches and Management of Refractory Diseases. Berlin, Germany: Springer-Verlag; 1996:178-184.
- Rowe JM. Treatment of acute myeloid leukemia with cytokines: effect on duration of neutropenia and response to infections. Clin Infect Dis. 1998;26:1290-1294.
- Rowe JM, Anderson JW, Mazza JJ, et al. A randomized placebo-controlled phase III study of granulocyte-macrophage colony-stimulating factor in adult patients (>55 to 70 years of age) with acute myelogenous leukemia: a study of the Eastern Cooperative Oncology Group (E1490). Blood. 1995;86:457-462.
- Nemunaitis J, Rabinowe S, Singer JW, et al. Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer. N Engl J Med. 1991;324:1773-1778.
- Nemunaitis J, Rosenfeld CS, Ash R, et al. Phase III randomized, double-blind placebo-controlled trial of rhGM-CSF following allogeneic bone marrow transplantation.Bone Marrow Transplant. 1995;15:949-954.
- Data on file. Genzyme Corporation.