Mozobil for Autologous Stem Cell Mobilization

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01164345
First received: July 12, 2010
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Stem Cell Mobilization
Autologous Stem Cell Transplantation
Drug: Plerixafor
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Mobilisation success rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    speed of engraftment is determined by the time until recovery of blood counts after transplantation.


Estimated Enrollment: 20
Study Start Date: June 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mozobil and Neupogen

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164345

Locations
Israel
Chaim Sheba Medical Center
Tel-Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01164345     History of Changes
Other Study ID Numbers: SHEBA-09-7481-AN-CTIL
Study First Received: July 12, 2010
Last Updated: November 22, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
non-Hodgkin's lymphoma
Hodgkin's lymphoma
stem cell mobilization
autologous stem cell transplantation

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
JM 3100
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014