fostamatinib for Immune Mediated Anemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Immune Mediated 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. Cytopenia 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 test a study drug (fostamatinib) in people who have cytopenia after a blood stem cell transplant. Eligibility: People aged 18 to 75 years who have cytopenia after a blood stem cell transplant. Design: Participants will be screened. They will have a physical exam. They will have blood, urine, and stool tests. Fostamatinib is an oral tablet taken by mouth. Participants will take the pills 2 times a day for 12 weeks. Participants will have a medical assessment every 2 weeks; their vital signs will be checked, and they will have blood and stool tests. Participants must come to the NIH clinic for these visits in weeks 4 and 12. Other visits may be done by telephone or telehealth; the blood and stool tests can be sent to the researchers from a local lab. After 4 weeks, some participants may begin taking a higher dose of the drug. Participants will return for a final medical assessment 2 weeks after they finish taking the drug. Participants who complete this study and show evidence that fostamatinib has increased their blood cell counts may enroll in an extension study to continue taking fostamatinib.

Eligible Conditions

  • Immune Mediated Anemia
  • Chronic Graft Versus Host Disease
  • Immune Mediated Thrombocytopenia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Immune Mediated Anemia

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: weeks: 2, 4, 6, 8, 10, 12

12 weeks
Incidence and severity of chronic GVHD
Number of patients who achieved =50% steroid dose
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)
any time during the study
Proportion of subjects who achieve objective hematologic recovery within the 12-week treatment course
weeks: 2, 4, 6, 8, 10, 12
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

Trial Safety

Safety Progress

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

Other trials for Immune Mediated 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: weeks: 2, 4, 6, 8, 10, 12
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
2016First Recorded Clinical Trial
2 TrialsResearching Immune Mediated Anemia
270 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects must test negative for HIV, HBV, and HCV by standard serologic tests within the previous six months.
You have the ability to understand the investigational nature of the study and provide informed consent.
You have anemia, transfusion dependent, or defined as hemoglobin <9 g/dL for 3 consecutive available readings at least 2 weeks apart, after other cell lines have engrafted OR if hemoglobin 9-10 g/dL, subject must have symptomatic anemia or ongoing treatment for immune hemolytic anemia that have failed at least one line of therapy outlined above.

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.