Mozobil for Autologous Stem Cell Mobilization | NCT01164345

Studies
Mozobil for Autologous Stem Cell Mobilization

NCT01164345

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Dec 3, 2015Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

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

Interventions

Plerixafor

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jul 12, 2010

First Submission Date that Met QC Criteria

Jul 15, 2010

First Posted Date

Jul 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Label	Type	Description	Intervention Names
MOZOBIL	Experimental	treatment with mozobil for autologous stem cell collection	Drug: Plerixafor

Name	Type	Description	Arm Group Labels	Other Names
Plerixafor	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	4 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008228	Lymphoma, Non-Hodgkin
D006689	Hodgkin Disease

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

ID	Term
C088327	plerixafor
D000069585	Filgrastim

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates