Back to results

Mozobil for Autologous Stem Cell Mobilization

Primary Purpose

Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Stem Cell Mobilization

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Plerixafor

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring non-Hodgkin's lymphoma, Hodgkin's lymphoma, stem cell mobilization, autologous stem cell transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MOZOBIL

Arm Description

treatment with mozobil for autologous stem cell collection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

engraftment after transplantation

speed of engraftment is determined by the time until recovery of blood counts after transplantation.

Full Information

NCT ID

NCT01164345

First Posted

July 12, 2010

Last Updated

December 1, 2015

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01164345

Brief Title

Mozobil for Autologous Stem Cell Mobilization

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

non-Hodgkin's lymphoma, Hodgkin's lymphoma, stem cell mobilization, autologous stem cell transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MOZOBIL

Arm Type

Experimental

Arm Description

treatment with mozobil for autologous stem cell collection

Intervention Type

Drug

Intervention Name(s)

Plerixafor

Other Intervention Name(s)

Mozobil and Neupogen

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mobilisation success rate

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

engraftment after transplantation

Description

speed of engraftment is determined by the time until recovery of blood counts after transplantation.

Time Frame

100 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnon Nagler, MD

Organizational Affiliation

Chaim Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chaim Sheba Medical Center

City

Tel-Hashomer

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

Mozobil for Autologous Stem Cell Mobilization

We'll reach out to this number within 24 hrs