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B-cell inhibitor

fostamatinib for Blood Cancers

Phase 1
Waitlist Available
Led By Stefanie Sarantopoulos, MD, PhD
Research Sponsored by Stefanie Sarantopoulos, MD, PhD.
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 one and two years when fostamatinib administered after allogeneic hct
Awards & highlights

Study Summary

This trial will test whether a drug that blocks activated B cells can prevent or treat chronic graft vs host disease after stem cell transplant.

Eligible Conditions
  • Blood Cancers

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate maximum tolerated dose of fostamatinib delivered following allogenic transplantation
Secondary outcome measures
B-cell activation rate
B-cell death rate
Incidence of chronic graft vs host disease (cGVHD)
+2 more

Side effects data

From 2012 Phase 3 trial • 923 Patients • NCT01197521
21%
DIARRHOEA
19%
HYPERTENSION
9%
NASOPHARYNGITIS
9%
NAUSEA
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: fostamatinibExperimental Treatment1 Intervention
Subjects will receive fostamatinib 100 mg qd, 150 mg qd, or 100 mg bid with dosage determined by the modified continual reassessment method. The treatment period begins at baseline 90 days after transplant and continues for up to 1 year after transplant. In patients with steroid-refractory cGVHD who are also included on this study, these subjects also receive fostamatinib 100mg qd, 150mg qd, or 100mg bid dosage determined by the modified continual reassessment method.
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?

Stefanie Sarantopoulos, MD, PhD.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Stefanie Sarantopoulos, MD, PhDPrincipal Investigator - Duke University
Duke University Hospital, Durham VA Medical Center
Boston University School Of Medicine (Medical School)
Brigham & Women'S Hospital (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of Fostamatinib in Patients With cGVHD After Allogeneic Stem Cell Transplant
Stefanie Sarantopoulos, MD, PhD. 2016. "Evaluation of Fostamatinib in Patients With cGVHD After Allogeneic Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02611063.
~2 spots leftby Apr 2025
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