NCT01164345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

4.9 years

First QC Date

July 12, 2010

Last Update Submit

December 1, 2015

Conditions

Non-Hodgkin's LymphomaHodgkin's LymphomaStem Cell MobilizationAutologous Stem Cell Transplantation

Keywords

non-Hodgkin's lymphomaHodgkin's lymphomastem cell mobilizationautologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • engraftment after transplantation

    100 days

Study Arms (1)

MOZOBIL

EXPERIMENTAL

treatment with mozobil for autologous stem cell collection

Drug: Plerixafor

Interventions

PlerixaforDRUG

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.

Also known as: Mozobil and Neupogen
MOZOBIL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients eligible and planned for an autologous haematopoietic stem cell transplantation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • WBC count ≥2.5x109/L.
  • Absolute neutrophil count ≥1.5x109/L.
  • Platelet count ≥100x109/L
  • Adequate cardiac, renal, hepatic and pulmonary function sufficient to undergo apheresis and transplantation.
  • 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

You may not qualify if:

  • History of any acute or chronic leukemia (including myelodysplastic syndrome.
  • Prior allogeneic or autologous transplantation.
  • Inability to tolerate stem cell harvest.
  • Peripheral venous access not possible.
  • Pregnant or nursing women.
  • Positive serology for hepatitis B or C.
  • 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.
  • HIV positive.
  • Left ventricular ejection fraction \< 50%.
  • DLCO \< 50%.
  • Splenectomised or splenic irradiation.
  • Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study.
  • Treatment with other investigational drugs within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHodgkin Disease

Interventions

plerixaforFilgrastim

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Arnon Nagler, MD

    Chaim Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 16, 2010

Study Start

June 1, 2010

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

IL(1)