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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
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks: 2, 4, 6, 8, 10, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks: 2, 4, 6, 8, 10, 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 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%
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 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
3,929 Previous Clinical Trials
47,765,207 Total Patients Enrolled
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 have a low white blood cell count.I have been on a stable dose of my current medication for GVHD or cytopenias for at least 15 days.I have ITP or wAIHA linked to lymphoma, chronic leukemia, hepatitis, or HIV.My high blood pressure is not under control.My low blood cell counts are not caused by my immune system.I have no cancer history except for certain skin, cervical, or breast conditions.I am between 18 and 75 years old.I understand this study is experimental and I can give my consent.I have an immune disorder affecting my blood and treatments haven't worked or I still need regular transfusions or steroids.I have taken fostamatinib after a stem cell transplant.I am experiencing signs of organ transplant rejection.I have no health conditions that could interfere with the study drug.I am over 60 days post-bone marrow transplant with low platelet or red blood cell counts.My immune-related low blood cell counts improve with standard treatments.I have a low blood cell count caused by an autoimmune condition.I have controlled my high blood pressure with medication for at least a week.I have not taken any immune system targeting drugs in the last 30 days.I am a man who will use two forms of birth control or abstain from sex to prevent pregnancy during and for 1 month after the 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 do not have a severe mental health condition that affects my ability to understand this study.I have a blood disorder caused by my immune system or a transplant.
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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