Assessment of Tolerance of Mobilizing Peripheral Hematopoietic Stem Cells by Plerixafor in Sickle… (NCT02212535) | Clinical Trial Compass
CompletedPhase 1/2
Assessment of Tolerance of Mobilizing Peripheral Hematopoietic Stem Cells by Plerixafor in Sickle Cell Patients
France3 participantsStarted 2016-01-15
Plain-language summary
The purpose of this study is to assess the tolerance and efficacy of mobilizing hematopoietic stem cells after a single injection of plerixafor (0.24mg/kg) in 3 adult patients (or 5, if results of the first 3 patients are not reproducible) affected by sickle cell disease.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years old
* Affiliated or beneficiary of a health insurance regimen
* For women of childbearing age, not pregnant and use effective contraception during the entire participation in research.
* Affected by a major sickle cell SS or Sβ thalassemia whose diagnosis must have been confirmed by a study of hemoglobin.
* Have the potential indication of allogenic bone marrow and don't have identical-HLA siblings.
* Have a general condition corresponding to a functional index of Lansky ≥ 80%
* Have been treated and followed for at least the previous two years in a specialized center where they got a full assessment of their disease
* In addition to the general eligibility criteria, sickle cell patients must have one or more of the following risk factors despite hydroxyurea treatment with for at least 4 months, except in cases of bad tolerance to hydroxyurea:
* Severe recurrent vaso-occlusive episodes of duration \> 48 hours or having required hospitalization for more than 24 hours (defined by at least two episodes during the previous year or in the year preceding the setting up of regular transfusion protocol)
* And /or recurrent Acute Chest Syndrome (at least 2 episodes) - defined by the presence of a new pulmonary infiltration involving at least one complete pulmonary segment (but excluding atelectasis) with chest pain and/or fever (\> 38 5), and / or tachypnea, and / or wheezing or cough without infectious syndrome
* Osteonecrosis of 2 or more…