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Stem Cell Mobilizer
Plerixafor for Sickle Cell Disease (PISMO Trial)
Phase 1
Recruiting
Led By Joseph Rosenthal, 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
PISMO Trial 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.Check my eligibility
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.See study design
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.
PISMO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 hours (5 days) from the last injection of plerixafor
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 hours (5 days) from the last injection of plerixafor
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Toxicities
Secondary outcome measures
Hematopoietic Stem Cell Mobilization
Side effects data
From 2021 Phase 2 & 3 trial • 20 Patients • NCT0223187937%
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
PISMO 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
~720
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,448 Total Patients Enrolled
Joseph Rosenthal, MDPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
94 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never received gene therapy.I have sickle cell disease with a specific genetic makeup.I am able to care for myself but may not be able to do active work.I do not have any ongoing serious infections.I haven't taken G-CSF or plerixafor in the last 4 weeks.My kidneys work well, with a filtration rate of at least 60 ml/min.I have had a stroke or neurological issue lasting more than a day, confirmed by an MRI.I have had at least one episode of acute chest syndrome despite treatment.I've had regular blood transfusions (at least 8 a year) for over a year to prevent complications.My liver is functioning within the required limits.I have bone damage in two or more of my joints.My heart pumps well, with an ejection fraction over 50%.I agree to use effective birth control or practice abstinence during the study.I have a known bone marrow disorder.I've had 2 or more severe pain crises needing hospital care in the last year.I have had a stroke or neurological issue lasting more than a day.I have not had major surgery in the last 30 days.I've had 2 or more severe pain crises needing hospital care in the last 2 years.I do not have any serious infections needing major treatment.I have been diagnosed with pulmonary hypertension through a heart catheter test.I have been diagnosed with alpha thalassemia.I have been cancer-free for 5 years, except for treated skin cancer.I have had a bone marrow harvest within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Plerixafor
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current cohort size for this research project?
"Affirmative. Clinicaltrials.gov records that this trial is in the midst of recruiting participants, having been published on September 19th 2018 and edited most recently on February 17th 2022. The researchers are looking for 12 individuals at a single site."
Answered by AI
Are recruitment efforts ongoing for this clinical trial?
"Affirmative. Information posted on clinicaltrials.gov shows that this research trial, which was first published on September 19th 2018, is currently seeking volunteers. The study requires 12 participants to be recruited from 1 medical facility."
Answered by AI
What risks should patients be aware of when taking Plerixafor?
"As this is an early phase medical trial, the safety of Plerixafor has been rated as a 1 due to limited clinical data validating its efficacy and ensuring it is safe."
Answered by AI
Are minors within the parameters of this experiment?
"According to the specified requirements of this trial, eligible candidates must be aged between 18 and 40."
Answered by AI
Could you provide a synopsis of research done involving Plerixafor?
"At the moment, there are 18 ongoing investigations of Plerixafor in action, none reaching Phase 3. 54 different medical centres across America are participating in these studies, with a high concentration located in Seattle, Washington."
Answered by AI
What type of participant would be best suited for this research project?
"12 individuals are being admitted to this investigation, but they must meet the criteria of having anemia and sickle cell disorder while also falling within 18-40 years old."
Answered by AI
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