Mozobil for Autologous Stem Cell Mobilization

Sheba Medical Center

Status and phase

Completed

Phase 2

Conditions

Autologous Stem Cell Transplantation

Hodgkin's Lymphoma

Stem Cell Mobilization

Non-Hodgkin's Lymphoma

Treatments

Drug: Plerixafor

Study type

Interventional

Funder types

Other

Identifiers

NCT01164345

SHEBA-09-7481-AN-CTIL

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.