Mozobil for Autologous Stem Cell Mobilization
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|