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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 106 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~106 weeks
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 moreSide effects data
From 2012 Phase 3 trial • 923 Patients • NCT0119752121%
DIARRHOEA
19%
HYPERTENSION
9%
NAUSEA
9%
NASOPHARYNGITIS
7%
HEADACHE
7%
ALANINE AMINOTRANSFERASE INCREASED
5%
BLOOD PRESSURE INCREASED
5%
URINARY TRACT INFECTION BACTERIAL
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
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
3,889 Previous Clinical Trials
47,834,187 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a severe mental illness that prevents me from understanding this study.I agree to use two forms of birth control or abstain from sex to avoid pregnancy during and for 1 month after the study.I am a man who will use two forms of birth control and not donate sperm during and for 1 month after the study.I have signs of my body rejecting a transplant, confirmed by tests.I have low blood cell counts not caused by my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Fostamatinib Arm
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.
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