STEM CELL MOBILIZATION WITH HIGH-DOSE PLERIXAFOR IN PATIENTS WITH SICKLE CELL DISEASE

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-25
SponsorHospital Israelita Albert Einstein

About this trial

The objective of this study is to demonstrate whether high-dose plerixafor can effectively mobilize hematopoietic stem cells in patients with sickle cell disease. It will also learn about the safety of this drug in higher doses in these patients. The main questions it aims to answer are:

Does high-dose plerixafor mobilize enough hematopoietic stem cells? What medical problems do participants have when taking high-dose plerixafor?

Participants will:

Undergo transfusion Take high-dose plerixafor Be submitted to stem cell collection by apheresis Visit the clinic 10 days after the procedure Be contacted by the research team 30 days after the procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Plerixafor Dose Escalation

    Drug

    Plerixafor will be administered as a single dose of 480 mcg/kg.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Arm A: high-dose plerixaforExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CD34⁺ cell count

Proportion of patients who achieve a CD34⁺ cell count \> 5 × 10⁶/kg body weight after HSC collection using plerixafor at a dose of 480 µg/kg

Time frame
0 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Israelita Albert Einstein

Lead sponsor

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Collaborator

This trial is not recruiting at the moment. You can still explore other options: