Mozobil for Autologous Stem Cell Mobilization

December 1, 2015 updated by: Sheba Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Hashomer, Israel
        • Chaim Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MOZOBIL
treatment with mozobil for autologous stem cell collection
Drug: Plerixafor
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.
Other Names:
  • Mozobil and Neupogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobilisation success rate
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
engraftment after transplantation
Time Frame: 100 days
speed of engraftment is determined by the time until recovery of blood counts after transplantation.
100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

July 12, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (ESTIMATE)

July 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-09-7481-AN-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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