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Fostamatinib for Post-Transplant Cytopenias
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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 923 Patients • NCT01197521Trial Design
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- 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.
- Group 1: Fostamatinib Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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"
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."
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."
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