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Plerixafor for Sickle Cell Disease

Memorial Sloan Kettering Cancer Center, New York, NY
Sickle Cell DiseasePlerixafor - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and efficacy of the drug Plerixafor in patients with sickle cell disease.

Eligible Conditions
  • Sickle Cell Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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PF-07209326

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: ≥ 30/ul at either 6-12 hours or 24-48 hours post plerixafor.

up to 30 days
safety
Hour 48
efficacy

Trial Safety

Phase-Based Safety

1 of 3

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1
Enasidenib
1
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Side Effects for

Plerixafor
37%Bone pain
32%Upper Respiratory Tract Infection
26%Weight gain
16%Hyperuricemia
16%Injection Site Reaction
16%Hypocalcemia
16%Blood alkaline phosphatase increased
16%Upper respiratory infection
16%Rash
16%Headache
11%Urinary Tract Infection
11%Knee pain
11%Migraine
11%Elective surgery
11%Tinea corporis
11%Acute bronchitis
11%Acute sinusitis
11%Abscess
11%Pharyngitis
11%Fracture
11%Creatinine increased
11%Pruritic rash
11%Alanine aminotransferase increased
11%Arthralgia
11%Herpes simplex
11%Papular rash
11%Tooth extraction
5%Arthritis
5%Iron Deficiency Anemia
5%Anemia
5%Diarrhea
5%Tinnitus
5%Joint pain
5%Aspartate aminotransferase increased
5%Low back pain
5%Nausea
5%Skin Infection
5%Infectious Diarrhea
5%Hyperglycemia
5%Hypernatremia
5%Hyperkalemia
5%Bone mineral content decreased
5%Cellulitis
5%Otitis media
5%Tinea capitis
5%Ovarian cyst
This histogram enumerates side effects from a completed 2021 Phase 2 & 3 trial (NCT02231879) in the Plerixafor ARM group. Side effects include: Bone pain with 37%, Upper Respiratory Tract Infection with 32%, Weight gain with 26%, Hyperuricemia with 16%, Injection Site Reaction with 16%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Plerixafor
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Plerixafor · No Placebo Group · Phase 1

Plerixafor
Drug
Experimental Group · 1 Intervention: Plerixafor · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plerixafor
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: ≥ 30/ul at either 6-12 hours or 24-48 hours post plerixafor.

Who is running the clinical trial?

New York Blood CenterOTHER
23 Previous Clinical Trials
26,716 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,861 Previous Clinical Trials
591,418 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,007 Previous Clinical Trials
1,330,928 Total Patients Enrolled
SanofiIndustry Sponsor
2,077 Previous Clinical Trials
3,006,082 Total Patients Enrolled
Duke UniversityOTHER
2,235 Previous Clinical Trials
3,034,044 Total Patients Enrolled
Farid Boulad, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
198 Total Patients Enrolled
Christina Cho, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
82 Total Patients Enrolled
Roni Tamari, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
117 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

What is the intake capacity for this clinical investigation?

"Indeed, the data on clinicaltrials.gov verify that this research study is actively recruiting participants at present. The trial was debuted on September 1st 2014 and updated most recently in November 15th 2022 with a goal of including 25 patients from one site." - Anonymous Online Contributor

Unverified Answer

Has Plerixafor obtained certification from the Food and Drug Administration?

"Our in-house review team at Power scored Plerixafor's safety as a 1 due to the limited amount of data concerning its efficacy and security, characteristic of Phase 1 trials." - Anonymous Online Contributor

Unverified Answer

Is a person under the age of 50 qualified to participate in this medical experimentation?

"The prerequisites for entering this trial require that participants are aged 18 or above and not exceeding 65 years old." - Anonymous Online Contributor

Unverified Answer

Are there any eligibility requirements for participation in this medical trial?

"This medical trial is targeting 25 individuals aged between 18 and 65 suffering from anemia or sickle cell. Eligibility requirements include a ECOG performance score of 2 or lower, as well as Karnofsky score above 70%." - Anonymous Online Contributor

Unverified Answer

Has Plerixafor been previously studied in other clinical trials?

"Currently, 18 on-going studies are observing Plerixafor with none in the final stage of testing. 54 different medical trial sites across America; most notably Seattle, Washington houses a few of them." - Anonymous Online Contributor

Unverified Answer

Are there any recruitment opportunities for this experiment currently open?

"Affirmative, based on the information available at clinicaltrials.gov, this medical investigation is currently recruiting participants. The trial was initially posted in September 2014 and most recently updated on November 15th 2022. A total of 25 individuals will be accepted across one test site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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