A Phase 2 interventional study of Plerixafor 0.12 mg/kg in Lymphoma, Non-Hodgkin, Lymphoma, Hodgkin and Myeloma, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Status unknown at 1 site in Mexico. Per ClinicalTrials.gov, last updated 2017-08-10.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Phase 2, Interventional, and Treatment
Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. We want to demonstrate that half of the commonly prescribed dose can be safely administered once as a single dose in first attempt leading to apheresis yields of >2 x 106 CD34+ cells/kg body weight.
Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. Consecutive patients in autologous transplant protocol will receive mobilization consisted of daily subcutaneously G-CSF 10 mg/kg for 4 days and plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of apheresis. HSC collection was performed with a Cobe Spectra® or Spectra Optia® apheresis system. The planned target blood volume to be processed will be 4-fold total blood volume calculated according to patients' weight and size. Peripheral blood CD34+ counts will be analyzed using flow cytometry. For each ASCT, we aimed for target yields of at least 2 x 106 CD34+cells/kg. Toxicities and engraftment will be documented.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 79 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Plerixafor 0.12 mg/kg SC will be administered in the evening, 11 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.
Drug: Plerixafor 0.12 mg/kg
Subcutaneously G-CSF 10 mg/kg for 4 days. At day four SC plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of aphaeresis.
Also known as: mozobil
Harvest of of at least 2 x106 CD34+/kg
percentage of patients with a target yields of at least 2 x 106 CD34+ cells/kg in one single aphaeresis procedure.
Time frame: 5 days
Time to engraftment
Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl
Time frame: 100 days
Rate of patients reaching a peripheral blood precount higher than 20 cells/μL
Rate of patients reaching a peripheral blood precount higher than 20 cells/μL
Time frame: 5 days
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Dr. Jose E. Gonzalez