Mozobil for Autologous Stem Cell Mobilization

Study Overview
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Brief Summary
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The aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL) patients for autologous transplantation.

Official Title
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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

Conditions
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Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Stem Cell Mobilization, Autologous Stem Cell Transplantation

Intervention / Treatment
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* Drug: Plerixafor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients eligible and planned for an autologous haematopoietic stem cell transplantation. 1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 1.2 WBC count ≥2.5x109/L. 1.3 Absolute neutrophil count ≥1.5x109/L. 1.4 Platelet count ≥100x109/L 1.5 Adequate cardiac, renal, hepatic and pulmonary function sufficient to undergo apheresis and transplantation. 1.6 Previously, heavily pretreated lymphoma patients or patients suspected to have a poor bone marrow stem cell reserve for at least one of the following: >2 lines of chemotherapy. Previous radiotherapy involving bone marrow Prior therapy with specific stem cell toxic chemotherapeutic agents Platelets count pre-mobilisation, ≤150.103 x mm3 Level of circulating CD34+ ≤ 20 cells/mcL prior to apheresis on the collection day Patients > 60 years of age Exclusion Criteria: 2.1 Lymphoma patients that did not fulfil the inclusion criteria. 2.2 History of any acute or chronic leukemia (including myelodysplastic syndrome. 2.3 Prior allogeneic or autologous transplantation. 2.4 Inability to tolerate stem cell harvest. 2.5 Peripheral venous access not possible. 2.6 Pregnant or nursing women. 2.7 Positive serology for hepatitis B or C. 2.8 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. 2.9 HIV positive. 2.10 Left ventricular ejection fraction < 50%. 2.11 DLCO < 50%. 2.12 Splenectomised or splenic irradiation. 2.13 Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study. 2.14 Treatment with other investigational drugs within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOZOBIL<br>treatment with mozobil for autologous stem cell collection | Drug: Plerixafor<br>* 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.<br>* Other names: Mozobil and Neupogen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobilisation success rate | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| engraftment after transplantation | speed of engraftment is determined by the time until recovery of blood counts after transplantation. | 100 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-Hodgkin's lymphoma, Hodgkin's lymphoma, stem cell mobilization, autologous stem cell transplantation