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Syk Inhibitor

Fostamatinib for Immune Thrombocytopenia (ITP)

Phase 2
Waitlist Available
Led By Richard W Childs, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 106 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will last about 2 years.

Who is the study for?
This trial is for people who've had a blood stem cell transplant and are experiencing low blood cell counts. They must have responded well to fostamatinib in a previous study, not be pregnant or breastfeeding, have certain minimum levels of platelets and hemoglobin, agree to use effective birth control, and not suffer from severe psychiatric illness or other health conditions that could interfere with the study.
What is being tested?
The trial is testing the long-term effects of fostamatinib on patients with cytopenia after a stem cell transplant. Participants will continue taking the same dose they received in an earlier phase of research for up to 21 months, with regular medical assessments and blood tests every month and every three months respectively.
What are the potential side effects?
While specific side effects are not listed here, participants can expect potential side effects similar to those experienced during the initial phase II trial. These may include issues related to drug absorption, metabolism or excretion as indicated by eligibility criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~106 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 106 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of subjects who are able to maintain hematologic recovery
Secondary study objectives
Adrenal Cortex Hormones
Change in the dose of other immunosuppressive agents
Proportion of subjects who are able to completely taper off fostamatinib while maintaining hematologic recovery
+1 more

Side effects data

From 2012 Phase 3 trial • 923 Patients • NCT01197521
21%
DIARRHOEA
19%
HYPERTENSION
9%
NAUSEA
9%
NASOPHARYNGITIS
7%
HEADACHE
7%
ALANINE AMINOTRANSFERASE INCREASED
5%
URINARY TRACT INFECTION BACTERIAL
5%
BLOOD PRESSURE INCREASED
5%
ABDOMINAL PAIN UPPER
4%
ASPARTATE AMINOTRANSFERASE INCREASED
3%
RHEUMATOID ARTHRITIS
3%
VOMITING
3%
BACK PAIN
1%
ATRIAL FIBRILLATION
1%
GASTROENTERITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD
FOSTA 100 MG BID
PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period
PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period

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: Fostamatinib ArmExperimental Treatment1 Intervention
The subjects will receive oral fostamatinib daily for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fostamatinib
2011
Completed Phase 3
~2680

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,935 Previous Clinical Trials
47,792,311 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Richard W Childs, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
18 Previous Clinical Trials
8,736 Total Patients Enrolled
Jamie Y Hur, D.O.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Fostamatinib (Syk Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05509582 — Phase 2
Graft-versus-Host Disease Research Study Groups: Fostamatinib Arm
Graft-versus-Host Disease Clinical Trial 2023: Fostamatinib Highlights & Side Effects. Trial Name: NCT05509582 — Phase 2
Fostamatinib (Syk Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05509582 — Phase 2
~13 spots leftby Dec 2028
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