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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
Author(s) -
Zhu Jun,
Huang Huiqiang,
Chen Huan,
Zhang Xi,
Li Zengjun,
Wu Depei,
Zhou Daobin,
Song Yongping,
Hu Yu,
Liang Yingmin,
Ren Hanyun,
Huang He,
Li Naig,
Chen Hu,
Hu Jiong,
Li Jianyong,
Meng Robin,
Wu Junlong,
Yu Dong,
Huang Xiaojun
Publication year - 2018
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.14426
Subject(s) - plerixafor , medicine , granulocyte colony stimulating factor , apheresis , placebo , surgery , hematopoietic stem cell transplantation , transplantation , filgrastim , adverse effect , lymphoma , clinical endpoint , randomized controlled trial , gastroenterology , chemotherapy , cxcr4 , pathology , platelet , chemokine , receptor , alternative medicine
BACKGROUND 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. STUDY DESIGN AND METHODS 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 × 10 6 CD34+ cells/kg or greater over no more than 4 days of apheresis. Other endpoints included the collection of 2 × 10 6 CD34+ cells/kg or greater and safety. RESULTS Overall, 101 patients were enrolled, and 50 were randomized to each group. More patients in the plerixafor group achieved 5 × 10 6 CD34+ cells/kg or greater (62 vs. 20%; p < 0.0001) or 2 × 10 6 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%). CONCLUSION 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.