Low Dose Plerixafor Plus G-CSF in Mobilizing Stem Cells for Autologous Peripheral Blood Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Low Dose Plerixafor Plus G-CSF Efficiency in Mobilizing Stem Cells From Lymphoma and Myeloma Patients for Autologous Peripheral Blood Transplantation

Conditions
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Myeloma, Lymphoma, Non-Hodgkin, Lymphoma, Hodgkin, Stem Cell Transplant Complications

Intervention / Treatment
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* Drug: Plerixafor 0.12 mg/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates planned for an autologous haematopoietic stem cell transplantation without previous mobilization attempts with chemotherapy. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. WBC count ≥2.5x109/L. Absolute neutrophil count ≥1.5x109/L. Platelet count ≥100x109/L Exclusion Criteria: Prior allogeneic or autologous transplantation. Pregnant women. Acute infection (febrile, i.e. temperature > 38C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF. Positive serology for hepatitis B or C or HIV. Left ventricular ejection fraction < 40% AST ALT >2.5x or Creatinine >2 md/dL
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, open-labeled, single-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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<br>* 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.<br>* Other names: mozobil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to engraftment | Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl | 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 | 5 days |