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G-CSF plus plerixafor
The Effect of Rituximab on Mobilization With AMD3100 (Plerixafor) Plus G-CSF in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD)
Ensayo de Sanofi en Non-Hodgkin Lymphoma · Hodgkin Disease (del registro, en inglés).
Más ensayos de: Linfoma no Hodgkin.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 30
- Centros
- 1
- Fin del objetivo primario
- jun 2009
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2006.
Qué mide
Summary of Adverse Events (AEs) (Day 1 and up to Day 59 (maximum time before start of chemotherapy)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroParticipants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one of 2 arms based on the immunophenotype of their lymphoma. (A)Participants with CD20(-) lymphoma will undergo mobilization with granulocyte colony-stimulating factor (G-CSF) and plerixafor. (B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and plerixafor. They will receive a weekly dose of rituximab beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF. Participants in both groups will receive G-CSF twice daily for 4 days. In the evening on Day 4, a dose of plerixafor will be administered. Apheresis will be initiated the next morning. Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until ≥5\*10\^6 CD34+ cells/kg are collected. Participants who are transplanted will be monitored for the time to polymorphonuclear leukocytes (PMN), platelets (PLT), and lymphocyte engraftment. Follow-up assessments will be done at 100 days, and 6 and 12 months post-transplantation.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00444912), actualizada en feb 2014.