Mozobil for Autologous Stem Cell Mobilization
|ClinicalTrials.gov Identifier: NCT01164345|
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : December 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Stem Cell Mobilization Autologous Stem Cell Transplantation||Drug: Plerixafor||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Plerixafor (Plerixafor AMD 3100) + Recombinant Human G-CSF (rhG-CSF) for Autologous Peripheral Blood Stem Cell Transplantation (AutoSCT) in Hard to Mobilise Patients: a Phase IIB Study|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
treatment with mozobil for autologous stem cell collection
Plerixafor (mozobil) 240 mcg/kg SC will be administered in the evening, 10 hours prior to initiation of apheresis.G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.
Other Name: Mozobil and Neupogen
- Mobilisation success rate [ Time Frame: 4 weeks ]Mobilisation success rate is defined as the mobilisation of a PBSC graft containing >2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach >2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching >5x10 CD34+ cells/kg in ≤ 4 apheresis sessions.
- engraftment after transplantation [ Time Frame: 100 days ]speed of engraftment is determined by the time until recovery of blood counts after transplantation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164345
|Chaim Sheba Medical Center|
|Principal Investigator:||Arnon Nagler, MD||Chaim Sheba Medical Center|