Mozobil for Autologous Stem Cell Mobilization

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma; Stem Cell Mobilization; Autologous Stem Cell Transplantation; Hodgkin's Lymphoma
• Interventions: Drug: Plerixafor

• Registration Number: NCT01164345
• Lead Sponsor: Sheba Medical Center

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 autologous transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-12
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MOZOBIL	Plerixafor	treatment with mozobil for autologous stem cell collection

Primary Outcome Measures

Name	Time	Method
Mobilisation success rate	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
engraftment after transplantation	100 days	speed of engraftment is determined by the time until recovery of blood counts after transplantation.

Trial Locations

Locations (1)

Chaim Sheba Medical Center; 🇮🇱 Tel-Hashomer, Israel