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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

Phase 2
18 Years
75 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Stem Cell Mobilization, Autologous Stem Cell Transplantation

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mobilisation success rate

Outcome Description:

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.

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Arnon Nagler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chaim Sheba Medical Center


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

June 2010

Completion Date:

July 2013

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Stem Cell Mobilization
  • Autologous Stem Cell Transplantation
  • non-Hodgkin's lymphoma
  • Hodgkin's lymphoma
  • stem cell mobilization
  • autologous stem cell transplantation
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin