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Plerixafor for Sickle Cell Disease

Phase 2
Waitlist Available
Led By Mitch Weiss, MD, PhD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days
Awards & highlights

Study Summary

This trial will test the safety and feasibility of collecting peripheral blood stem cells from pediatric and young adult patients with sickle cell disease after administering plerixafor. The hope is that studying these peripheral blood stem cells will help in optimizing the yield of peripheral CD34+ cells from pediatric and young adult patients with sickle cell disease, which in turn will help to develop better gene therapies for these patients.

Eligible Conditions
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with sufficient collection of hematopoietic stem cells (HSCs) without serious adverse events.

Side effects data

From 2021 Phase 2 & 3 trial • 20 Patients • NCT02231879
37%
Bone pain
32%
Upper Respiratory Tract Infection
26%
Weight gain
16%
Blood alkaline phosphatase increased
16%
Upper respiratory infection
16%
Injection Site Reaction
16%
Hyperuricemia
16%
Hypocalcemia
16%
Headache
16%
Rash
11%
Tooth extraction
11%
Herpes simplex
11%
Urinary Tract Infection
11%
Abscess
11%
Pharyngitis
11%
Tinea corporis
11%
Fracture
11%
Migraine
11%
Acute bronchitis
11%
Elective surgery
11%
Acute sinusitis
11%
Alanine aminotransferase increased
11%
Creatinine increased
11%
Knee pain
11%
Arthralgia
11%
Papular rash
11%
Pruritic rash
5%
Iron Deficiency Anemia
5%
Cellulitis
5%
Arthritis
5%
Nausea
5%
Skin Infection
5%
Tinea capitis
5%
Aspartate aminotransferase increased
5%
Anemia
5%
Tinnitus
5%
Diarrhea
5%
Infectious Diarrhea
5%
Otitis media
5%
Bone mineral content decreased
5%
Hyperglycemia
5%
Hypernatremia
5%
Hyperkalemia
5%
Joint pain
5%
Low back pain
5%
Ovarian cyst
100%
80%
60%
40%
20%
0%
Study treatment Arm
Plerixafor
G-CSF

Trial Design

1Treatment groups
Experimental Treatment
Group I: PlerixaforExperimental Treatment1 Intervention
Participants will receive a subcutaneous dose of 0.24 mg/kg of plerixafor once daily (Q24hr) x 2 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plerixafor
2011
Completed Phase 3
~720

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,613 Total Patients Enrolled
Doris Duke Charitable FoundationOTHER
61 Previous Clinical Trials
260,086 Total Patients Enrolled
Mitch Weiss, MD, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the possible adverse effects of Plerixafor?

"While there is some data supporting Plerixafor's safety, none of it points to the medication being effective. Therefore, we've given it a score of 2."

Answered by AI

How many people are signing up for this clinical trial?

"That is correct. The clinicaltrials.gov website contains information revealing that this trial is actively looking for subjects. This research was initially posted on November 1st, 2022 and has been edited as recently as October 28th, 2022. 15 individuals are needed at a single site."

Answered by AI

Could I take part in this experiment if I meet the requirements?

"This trial is only for young people between the ages of 10 and 25 who have anemia and sickle cell. recruitment is still open for around 15 more patients."

Answered by AI

Are participants being sought for this research project at present?

"Yes, the information on clinicaltrials.gov suggests that this trial is actively recruiting participants. The clinical trial was first posted on 11/1/2022 and was most recently edited on 10/28/2022. The trial is enrolling 15 patients across 1 locations"

Answered by AI

Does this experiment only use test subjects who are middle-aged or younger?

"According to the age range delineated in the inclusion criteria, patients as young as 10 and no older than 25 years old may participate."

Answered by AI

To what extent has Plerixafor been researched in the past?

"At this time, 18 different clinical trials are underway for Plerixafor. Of these active studies, 0 have reached Phase 3. Usually based in Seattle, Washington, there are 54 medical locations running trials for Plerixafor across the United States of America."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Peripheral Blood Stem Cell Collection From Patients With Sickle Cell Disease (SCD) Using Plerixafor
2023. "Peripheral Blood Stem Cell Collection From Patients With Sickle Cell Disease (SCD) Using Plerixafor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817345.
~0 spots leftby Apr 2025
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