Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005775

Trial Description

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Title

Plerixafor as a Salvage Regimen to Mobilize Allogeneic Stem Cells in Healthy Volunteers

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Trial Acronym

MOBIL1

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URL of the Trial

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Brief Summary in Lay Language

With a standard mobilization regimen using G-CSF, approximately 5% of allogeneic donors does
not mobilize enough CD34+ cells to reach an optimal dose for transplantation and are
therefore called "poor mobilizers". A generally accepted optimum CD34+ PBSC dose for
allogeneic transplantation is > 4.5 x 106/kg body weight of the recipient. The minimum total
CD34+ PBSC dose certainly amounts to 2 x 106/kg body weight of the recipient.The objective
of this trial is to assess the efficacy of a single dose of Plerixafor as salvage procedure
in allogeneic stem cell donors with a poor CD34+ cell yield after the first day of
peripheral blood stem cell collection.

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Brief Summary in Scientific Language

In this trial the administration of a single dose of Plerixafor 240 µg/kg body weight of the
donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1 will be
provided. The apheresis on day 2 is performed according to standard recommendations.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005775
  •   2014/02/14
  •   2013/09/27
  •   yes
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Secondary IDs

  •   NCT01954914  (ClinicalTrials.gov)
  •   TUD-MOBIL1-056  (Technische Universität Dresden)
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Health Condition or Problem studied

  •   Blood Stem Cell Harvest Failure
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Interventions/Observational Groups

  •   Drug: Plerixafor
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Rate of donation success; time frame: 1 day; A generally accepted optimum CD34+ PBSC dose for allogeneic transplantation is > 4.5 x 10e6/kg body weight of the recipient. The minimum total CD34+ PBSC dose certainly amounts to 2 x 10e6/kg body weight of the recipient.

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Secondary Outcome

- Assessment of donor safety and tolerability based on self-reporting on a questionnaire, clinical findings, and laboratory evaluations; and evaluation of the cellular composition of the apheresis products collected with and without Plerixafor application.; time frame: 30 days; The composition of apheresis products collected after filgrastim or filgrastim plus Plerixafor will be characterized with respect to:
CD34+ cell subsets (differential expression of prominin1/CD133+)33
Regulatory T-cells34
Dendritic cells
Myeloid-derived suppressor cells

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2013/12/31
  •   37
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Donor age between 18 years and 75 years

- Eligibility of the donor for allogeneic PBSC donation according to German Guidelines
(Richtlinien Hämotherapie Bundesärztekammer 2005) preceding the application of G-CSF

- The donor has understood and signed the donor information. Written informed consent
has been obtained.

- Donation of less than 2.0 x 106 CD34 cells/kg recipient body weight after one
apheresis following five days of stem-cell mobilization with Lenograstim 7.5 to 10
µg/kg donor body weight

- First leukapheresis according to standard recommendations with a processing of 3 x
donor's blood volume ± 10% using either of the following three devices: Cobe Spectra
(Terumo BCT) Spectra Optia (Terumo BCT) Fresenius COM.TEC

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Exclusion Criteria

- Pain or any discomfort in the left upper square of the abdomen during physical
examination immediately prior to study inclusion or any spontaneous complaint about
abdominal discomfort without an ultrasound investigation which rules out
splenomegaly.

- Palpitations or any thoracic discomfort in the absence of an ECG which shows normal
results

- Platelet count < 80 x 109/l

- Serum creatinine > 80 µmol/l for female donors or > 106 µmol/l for male donors. If
serum creatinine is elevated then the estimated creatinine clearance has to be > 50
ml/min. Estimation by the Modification of Diet in Renal Disease equation where
predicted GFR(ml/min/1.73m2) = 186 x (Serum Creatinine in mg/dL)-1.154 x (age in
years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black) or
GFR(ml/min/1.73m2) = 186 x 176 (Serum Creatinine in µmol/l)-1.154 x (age in
years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black)

- Contraindications against a second leukapheresis, such as severe side effects during
1st leukapheresis (intolerable pain, severe circulatory disorder, severe citrate
intolerance)

- Missing written approval by the transplant center that the transplantation of the
Plerixafor-mobilized graft is being considered

- Treatment with any known non-marketed drug substance or experimental therapy within 4
weeks prior to enrolment or participation in any other interventional clinical study

- Any significant concurrent disease, illness, or psychiatric disorder that would
compromise donor safety or compliance, interfere with consent, study participation,
follow up, or interpretation of study results

- Female donors of childbearing potential unable or unwilling to use adequate
contraception methods for three months after the administration of the study drug.
Adequate methods for contraception in female donors are sexual abstinence, the use of
condoms by their partners, vasectomy of the partner or hormonal contraception.

- Male donors unable or unwilling to use adequate contraception methods for one month
after the administration of the study drug. Adequate methods for contraception for
males are sexual abstinence or the use of condoms.

- Known intolerance to Plerixafor

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Addresses

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    • Technische Universität Dresden
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    • University Hospital Carl Gustav Carus
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    • Cellex Gesellschaft für Zellgewinnung mbH Dresden
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    • Cellex Gesellschaft für Zellgewinnung mbH Köln
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    • Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
    • Kristina Hölig, Dr. med. 
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    • Kristina Hölig, Dr. med. 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.