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Stem Cell Mobilizer

Plerixafor for Sickle Cell Disease (PISMO Trial)

Phase 1
Waitlist Available
Led By Leo Wang, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 hours (5 days) from the last injection of plerixafor
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if two doses of a medication called plerixafor is a safe and effective way to get enough healthy blood cells for a transplant in people with sickle cell disease.

Who is the study for?
This trial is for individuals with sickle cell disease who weigh between 50-120 kg and have experienced severe pain crises or other complications like stroke, acute chest syndrome, or osteonecrosis. They should have good organ function and no history of certain conditions like alpha thalassemia, HIV/HTLV, uncontrolled infections, malignancy (except some skin cancers), recent major surgery, or prior gene therapy.
What is being tested?
The study tests whether two injections of Plerixafor are safe and effective in mobilizing enough CD34+ stem cells for autologous transplantation in patients with sickle cell disease. It aims to improve treatment by potentially enabling successful transplants.
What are the potential side effects?
Plerixafor may cause side effects such as gastrointestinal symptoms (nausea, diarrhea), injection site reactions (pain or swelling), tiredness, headache, dizziness, and potential allergic reactions among others.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 hours (5 days) from the last injection of plerixafor
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 hours (5 days) from the last injection of plerixafor for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Toxicities
Secondary study objectives
Hematopoietic Stem Cell Mobilization

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%
Abscess
11%
Tooth extraction
11%
Pharyngitis
11%
Herpes simplex
11%
Urinary Tract Infection
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%
Arthritis
5%
Cellulitis
5%
Skin Infection
5%
Iron Deficiency Anemia
5%
Nausea
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PlerixaforExperimental Treatment1 Intervention
Up to two subcutaneous injections of plerixafor (starting dose level: 240 µg/kg/dose)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plerixafor
2011
Completed Phase 3
~710

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,575 Total Patients Enrolled
Leo Wang, MDPrincipal InvestigatorCity of Hope Medical Center
Joseph Rosenthal, MDPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
94 Total Patients Enrolled

Media Library

Plerixafor (Stem Cell Mobilizer) Clinical Trial Eligibility Overview. Trial Name: NCT03664830 — Phase 1
Sickle Cell Disease Research Study Groups: Plerixafor
Sickle Cell Disease Clinical Trial 2023: Plerixafor Highlights & Side Effects. Trial Name: NCT03664830 — Phase 1
Plerixafor (Stem Cell Mobilizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03664830 — Phase 1
~0 spots leftby Dec 2024
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