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.

Abstract

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 × 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.

RESULTS:

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%; p < 0.0001) 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%).

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.

• Authors: Jun Zhu, Huiqiang Huang, Huan Chen, Xi Zhang, Zengjun Li, Depei Wu, Daobin Zhou, Yongping Song, Yu Hu, Yingmin Liang, Hanyun Ren, He Huang, Nainong Li, Hu Chen, Jiong Hu, Jianyong Li, Robin Meng, Junlong Wu, Dong Yu, Xiaojun Huang
• Journal: Transfusion (Transfusion) Vol. 58 Issue 1 Pg. 81-87 (01 2018) ISSN: 1537-2995 [Electronic] United States
• PMID: 29238988 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2017 AABB.

Chemical References

• Benzylamines
• Cyclams
• Heterocyclic Compounds
• Granulocyte-Macrophage Colony-Stimulating Factor
• plerixafor

Topics

• Adolescent
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Benzylamines
• China
• Combined Modality Therapy
• Cyclams
• Double-Blind Method
• Drug Synergism
• Gastrointestinal Diseases (chemically induced)
• Granulocyte-Macrophage Colony-Stimulating Factor (administration & dosage, pharmacology)
• Hematopoietic Stem Cell Mobilization (adverse effects, methods)
• Heterocyclic Compounds (administration & dosage, adverse effects, pharmacology)
• Humans
• Hypokalemia (chemically induced)
• Lymphoma, Non-Hodgkin (drug therapy, therapy)
• Middle Aged
• Nervous System Diseases (chemically induced)
• Peripheral Blood Stem Cell Transplantation
• Remission Induction
• Transplantation, Autologous
• Treatment Outcome
• Young Adult