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

July 12, 2010
November 22, 2013
June 2010
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01164345 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Mozobil for Autologous Stem Cell Mobilization
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Stem Cell Mobilization
  • Autologous Stem Cell Transplantation
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
Experimental: MOZOBIL
treatment with mozobil for autologous stem cell collection
Intervention: Drug: Plerixafor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
July 2014
July 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01164345
SHEBA-09-7481-AN-CTIL
No
Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center
Sheba Medical Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP