Status:
COMPLETED
Mozobil for Autologous Stem Cell Mobilization
Lead Sponsor:
Sheba Medical Center
Conditions:
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 autologo...
Eligibility Criteria
Inclusion
- Patients eligible and planned for an autologous haematopoietic stem cell transplantation.
- 1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- 2 WBC count ≥2.5x109/L.
- 3 Absolute neutrophil count ≥1.5x109/L.
- 4 Platelet count ≥100x109/L
- 5 Adequate cardiac, renal, hepatic and pulmonary function sufficient to undergo apheresis and transplantation.
- 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
- 1 Lymphoma patients that did not fulfil the inclusion criteria.
- 2 History of any acute or chronic leukemia (including myelodysplastic syndrome.
- 3 Prior allogeneic or autologous transplantation.
- 4 Inability to tolerate stem cell harvest.
- 5 Peripheral venous access not possible.
- 6 Pregnant or nursing women.
- 7 Positive serology for hepatitis B or C.
- 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.
- 9 HIV positive.
- 10 Left ventricular ejection fraction \< 50%.
- 11 DLCO \< 50%.
- 12 Splenectomised or splenic irradiation.
- 13 Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study.
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01164345
Start Date
June 1 2010
End Date
May 1 2015
Last Update
December 3 2015
Active Locations (1)
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1
Chaim Sheba Medical Center
Tel Litwinsky, Israel