fostamatinib for Anemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Anemia+3 More
fostamatinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Background: People who have a blood stem cell transplant can sometimes develop cytopenia. This means that their levels of one or more types of blood cell, such as the red cells or platelets, are lower than they should be. This can occur because a person s immune system might attack these cells after a stem cell transplant. Up to 20% of people who have blood stem cell transplants develop cytopenias, which can lead to anemia, severe bleeding, infections, and other problems. Treatments are needed to help keep blood cell levels stable after blood stem cell transplant. Objective: To evaluate the long-term effects of a study drug (fostamatinib) in people with cytopenia after a blood stem cell transplant. Eligibility: People who responded well to fostamatinib in an earlier study. Design: Participants will be screened. They will have a physical exam and blood tests. Fostamatinib is an oral tablet taken by mouth. Participants will take the pills at the same dose and frequency as they did during the previous study. They will take the pills for up to 21 months. The dosage of the drug may be reduced over time if their blood cell levels are stable. Participants will have a medical assessment every month. This can be with their local doctor or at the NIH clinic. Participants will have blood tests every 3 months. Participants will have a follow-up visit after they stop taking the drug. Their vital signs will be taken, and they will have blood drawn. They will answer questions about their health.

Eligible Conditions

  • Anemia
  • Thrombocytopenia
  • Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Anemia

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 106 weeks

106 weeks
Proportion of subjects who are able to completely taper off fostamatinib while maintaining hematologic recovery
Proportion of subjects who are able to taper off fostamatinib by >33% while maintaining hematologic recovery
12 weeks
Change in corticosteroid dose
Change in the dose of other immunosuppressive agents
Proportion of subjects who are able to maintain hematologic recovery

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Anemia

Side Effects for

FOSTA 100 MG BID (4 WKS) THEN 150 MG QD
21%DIARRHOEA
19%HYPERTENSION
9%NASOPHARYNGITIS
9%NAUSEA
7%ALANINE AMINOTRANSFERASE INCREASED
7%HEADACHE
5%ABDOMINAL PAIN UPPER
5%URINARY TRACT INFECTION BACTERIAL
5%BLOOD PRESSURE INCREASED
4%ASPARTATE AMINOTRANSFERASE INCREASED
3%VOMITING
3%BACK PAIN
3%RHEUMATOID ARTHRITIS
1%ATRIAL FIBRILLATION
1%GASTROENTERITIS
0%APPENDICITIS
0%ANGIOEDEMA
0%PERIPHERAL ISCHAEMIA
0%METRORRHAGIA
0%CHORIORETINOPATHY
0%COLITIS
0%COLONIC OBSTRUCTION
0%ACUTE MYOCARDIAL INFARCTION
0%ANAEMIA
0%CARDIAC FAILURE
0%ATRIAL FLUTTER
0%CARDIAC FAILURE ACUTE
0%CARDIOPULMONARY FAILURE
0%DUODENAL ULCER HAEMORRHAGE
0%GASTRITIS ATROPHIC
0%ATRIAL THROMBOSIS
0%REFLUX GASTRITIS
0%PANCREATITIS
0%CHOLECYSTITIS
0%BILE DUCT OBSTRUCTION
0%ANAPHYLACTIC REACTION
0%BILIARY COLIC
0%BACTERIAL DIARRHOEA
0%CHOLELITHIASIS
0%BRONCHITIS
0%GASTROENTERITIS VIRAL
0%CELLULITIS
0%PANCREATITIS VIRAL
0%ESCHERICHIA URINARY TRACT INFECTION
0%PULMONARY TUBERCULOSIS
0%PNEUMONIA
0%UPPER RESPIRATORY TRACT INFECTION
0%SEPSIS
0%ACCIDENTAL OVERDOSE
0%SEPTIC SHOCK
0%CONTUSION
0%FEMUR FRACTURE
0%URINARY TRACT INFECTION
0%HUMERUS FRACTURE
0%TIBIA FRACTURE
0%FIBULA FRACTURE
0%FEMORAL NECK FRACTURE
0%HIP FRACTURE
0%SPINAL FRACTURE
0%DEHYDRATION
0%SYSTEMIC LUPUS ERYTHEMATOSUS
0%OSTEOARTHRITIS
0%FOOT DEFORMITY
0%UTERINE LEIOMYOMA
0%BASAL CELL CARCINOMA
0%PATHOLOGICAL FRACTURE
0%THYROID CANCER
0%RENAL CANCER
0%SPONDYLOLISTHESIS
0%GASTRIC CANCER
0%MULTIPLE SCLEROSIS
0%ABORTION SPONTANEOUS
0%CALCULUS URINARY
0%GANGLIONEUROMA
0%RENAL ARTERY STENOSIS
0%HAEMORRHAGIC OVARIAN CYST
0%TRANSIENT GLOBAL AMNESIA
0%ISCHAEMIC STROKE
0%RENAL FAILURE ACUTE
0%CONFUSIONAL STATE
0%INTERSTITIAL LUNG DISEASE
0%HYPOTENSION
0%NEPHROLITHIASIS
0%ACUTE RESPIRATORY FAILURE
0%PULMONARY EMBOLISM
0%CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0%HYPOVOLAEMIC SHOCK
0%VITILIGO
0%CIRCULATORY COLLAPSE
0%DYSPNOEA
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01197521) in the FOSTA 100 MG BID (4 WKS) THEN 150 MG QD ARM group. Side effects include: DIARRHOEA with 21%, HYPERTENSION with 19%, NASOPHARYNGITIS with 9%, NAUSEA with 9%, ALANINE AMINOTRANSFERASE INCREASED with 7%.

Trial Design

1 Treatment Group

Fostamatinib Arm
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: fostamatinib · No Placebo Group · Phase 2

Fostamatinib Arm
Drug
Experimental Group · 1 Intervention: fostamatinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fostamatinib
2011
Completed Phase 3
~2660

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 106 weeks
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
Photo of maryland 1Photo of maryland 2Photo of maryland 3
2016First Recorded Clinical Trial
12 TrialsResearching Anemia
276 CompletedClinical Trials

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,555 Previous Clinical Trials
46,915,169 Total Patients Enrolled
99 Trials studying Anemia
18,411 Patients Enrolled for Anemia
Richard W Childs, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
18 Previous Clinical Trials
8,746 Total Patients Enrolled
4 Trials studying Anemia
244 Patients Enrolled for Anemia

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Hemoglobin > 9 g/dL (or at least > 1 g/dL above baseline) in subjects enrolled with posttransplant anemia without transfusion support, at least once during the 12-week phase II trial.
You have posttransplant Evan s syndrome.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.