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Plerixafor and granulocyte-colony-stimulating factor for mobilization of hematopoietic stem cells for autologous transplantation in Chinese patients with non-Hodgkin's lymphoma: a randomized Phase 3 study.
- Source :
-
Transfusion . Jan2018, Vol. 58 Issue 1, p81-87. 7p. 3 Charts. - Publication Year :
- 2018
-
Abstract
- <bold>Background: </bold>This Phase 3 randomized, double-blind study evaluated the efficacy and safety of plerixafor plus granulocyte-colony-stimulating factor for the mobilization of hematopoietic stem cells in Chinese patients with non-Hodgkin's lymphoma.<bold>Study Design and Methods: </bold>Adults (ages 18-75 years) with non-Hodgkin's lymphoma in first or second complete or partial remission, without previous hematopoietic stem cell mobilization or autologous transplant, were included. Patients received granulocyte-colony-stimulating factor 10 µg/kg/day from Days 1 through 4 before they were randomized (1:1) to receive either plerixafor 0.24 mg/kg/day or placebo subcutaneously on Days 4 through 7 plus continued granulocyte-colony-stimulating factor on Days 5 through 8. Apheresis began on Day 5 and continued for no more than 4 days. The primary endpoint was collection of 5 × 106 CD34+ cells/kg or greater over no more than 4 days of apheresis. Other endpoints included the collection of 2 × 106 CD34+ cells/kg or greater and safety.<bold>Results: </bold>Overall, 101 patients were enrolled, and 50 were randomized to each group. More patients in the plerixafor group achieved 5 × 106 CD34+ cells/kg or greater (62 vs. 20%; pā<ā0.0001) or 2 × 106 CD34+ cells/kg or greater (88 vs. 66%) and underwent transplantation (88 vs. 68%) compared with those in the placebo group. The most common plerixafor-related adverse events were nausea (7.8%) and diarrhea (3.9%).<bold>Conclusion: </bold>Plerixafor plus granulocyte-colony-stimulating factor is superior to placebo plus granulocyte-colony-stimulating factor for the mobilization of CD34+ cells for autologous transplantation and is generally well tolerated in Chinese patients with non-Hodgkin's lymphoma. [ABSTRACT FROM AUTHOR]
- Subjects :
- *GRANULOCYTE-colony stimulating factor
*COLONY-stimulating factors (Physiology)
*HEMATOPOIETIC stem cell transplantation
*BLOOD diseases
*AUTOTRANSPLANTATION
*IMMUNOMODULATORS
*CELL motility
*HEMATOPOIETIC stem cells
*LYMPHOMAS
*HEALTH outcome assessment
*STATISTICAL sampling
*TRANSPLANTATION of organs, tissues, etc.
*RANDOMIZED controlled trials
*BLIND experiment
*PHARMACODYNAMICS
Subjects
Details
- Language :
- English
- ISSN :
- 00411132
- Volume :
- 58
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- Transfusion
- Publication Type :
- Academic Journal
- Accession number :
- 127166039
- Full Text :
- https://doi.org/10.1111/trf.14426