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Tyrosine Kinase Inhibitor

Fostamatinib for Post-Transplant Cytopenias

Phase 2
Recruiting
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 weeks: 2, 4, 6, 8, 10, 12
Awards & highlights

Study Summary

This trial is testing a study drug (fostamatinib) in people who have cytopenia after a blood stem cell transplant to see if it helps keep blood cell levels stable.

Who is the study for?
Adults aged 18-75 with low blood cell counts after a stem cell transplant can join. They must use effective birth control, not have HIV/HBV/HCV, and be stable on current medications. Excluded are those with uncontrolled hypertension, recent biologic treatments, severe psychiatric issues, certain liver abnormalities, or other autoimmune causes of low blood cells.Check my eligibility
What is being tested?
The trial is testing fostamatinib tablets taken twice daily for 12 weeks to treat cytopenia in post-stem cell transplant patients. Participants will undergo regular medical assessments including physical exams and various tests at NIH clinics or via telehealth.See study design
What are the potential side effects?
Potential side effects of fostamatinib may include high blood pressure (hypertension), digestive disturbances like diarrhea or nausea, liver enzyme elevations indicating potential liver damage, and an increased risk of infections due to immune system effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks: 2, 4, 6, 8, 10, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks: 2, 4, 6, 8, 10, 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of subjects with stable hematologic recovery (improvement documented in 2 consecutive available readings) without recent blood product transfusion support (in the past 48-72 hours)
Secondary outcome measures
Average weekly number of transfused blood component of transfusion requirement or growth factor requirement (dose and number) of transfused blood components or growth factors support
Change in corticosteroid dose
Change in other immunosuppressant doseY
+3 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%
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fostamatinib ArmExperimental Treatment1 Intervention
The subjects will receive oral fostamatinib daily for 12 weeks.
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
3,847 Previous Clinical Trials
47,818,216 Total Patients Enrolled
1 Trials studying Immune Mediated Anemia
20 Patients Enrolled for Immune Mediated Anemia
Richard W Childs, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
18 Previous Clinical Trials
8,736 Total Patients Enrolled
1 Trials studying Immune Mediated Anemia
20 Patients Enrolled for Immune Mediated Anemia
Jamie Y Hur, D.O.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Immune Mediated Anemia
20 Patients Enrolled for Immune Mediated Anemia

Media Library

Fostamatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05502783 — Phase 2
Immune Mediated Anemia Research Study Groups: Fostamatinib Arm
Immune Mediated Anemia Clinical Trial 2023: Fostamatinib Highlights & Side Effects. Trial Name: NCT05502783 — Phase 2
Fostamatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05502783 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How reliable is fostamatinib in terms of side effects when administered?

"As there is no evidence of efficacy, our team at Power allocated a score on 2 out of 3 for fostamatinib's safety due to the Phase 2 trial that has been conducted."

Answered by AI

Who meets the criteria for enrolment in this research?

"This clinical trial is recruiting 20 individuals aged 18-75 afflicted with anemia and meeting the following criteria: HIV, HBV, and HCV negative within the last 6 months; women of reproductive potential must agree to use two types of birth control during treatment and for one month after its completion; men of reproductive potential must refrain from donating sperm during this period; failed or relapsed at least once line therapy including steroids; transfusion dependent (at least 1 transfusion/ 2 weeks); steroid dependence; thrombocytopenia (<30 x 10^9/L) not attributed to rescue transfusions, symptomatic anemia with"

Answered by AI

Is this investigation actively seeking participants aged 85 and over?

"This clinical trial looks for patients aged between 18 and 75. For those under the age of 18, there are 29 trials available, while 120 are offered to people over 65 years old."

Answered by AI

Is this investigation actively seeking individuals to join?

"Unfortunately, the clinical trial is no longer enrolling patients. It was posted on December 6th 2022 and its most current update happened November 30th of that same year. Nevertheless, there are 140 other trials in progress at this time looking for participants."

Answered by AI
~12 spots leftby Apr 2026