CompletedPhase 2

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

Germany39 participantsStarted 2013-12

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of donation success

Timeframe: 1 day

Trial details

NCT IDNCT01954914

SponsorTechnische Universität Dresden

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Blood Stem Cell Harvest Failure trials