Warm Antibody Autoimmune Hemolytic AnemiaPhase 2SOARNCT02612558
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
A Phase 2 study testing Fostamatinib 150 mg bid in people with Warm Antibody Autoimmune Hemolytic Anemia, run by Rigel Pharmaceuticals at 36 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Warm Antibody Autoimmune Hemolytic Anemia
- What is being tested?
- Fostamatinib 150 mg bid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Jul 2016to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have had a diagnosis of primary or secondary warm antibody AIHA.
- Must have failed at least 1 prior treatment regimen for AIHA.
Who cannot join
- Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria.
- Subject with a platelet count of < 30,000/μL.
- Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.
- Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States31 sites
Johns Hopkins University School Of Medicine
Baltimore, Maryland, 21205
Rcca Md Llc
Bethesda, Maryland, 20817
Massachusetts General Hospital
Boston, Massachusetts, 02114
Roswell Park Cancer Institute
Buffalo, New York, 14263
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Loma Linda University Cancer Center
Loma Linda, California, 92350
LAC/USC Health Center
Los Angeles, California, 90033
MidMichigan Health Cancer Center
Midland, Michigan, 48640
Froedtert Hospital
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
West Virginia University
Morgantown, West Virginia, 26506
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida, 32763
W.G. "Bill" Hefner VA Medical Center
Salisbury, North Carolina, 28144
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of Utah
Salt Lake City, Utah, 84132
Texas Oncology San Antonio Medical Center
San Antonio, Texas, 78240
University of California at San Francisco
San Francisco, California, 94158
University of Washington
Seattle, Washington, 98105
M. Francisco Gonzalez, M.D., P.A.
Sumter, South Carolina, 29150
Promedica Flower Hospital
Sylvania, Ohio, 43560
Montefiore Medical Center
The Bronx, New York, 10467
Arizona Oncology Associates, PC
Tucson, Arizona, 85711
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Clear Lake Specialties
Webster, Texas, 77598
The Oncology Institute of Hope and Innovation
Whittier, California, 90603
Canada5 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Hamilton Health Sciences- McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
Victoria Hospital
London, Ontario, N6A 5W9
Jewish General Hospital
Montreal, Quebec, H3T IE2
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
- Being tested
- Fostamatinib 150 mg bid
- Keywords
- Warm antibody autoimmune hemolytic anemia (AIHA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fostamatinib 150 mg bidDrug
Also called R935788, R788, Fostamatinib, Tavalisse
Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.
| Study group | Role | What they receive |
|---|---|---|
| Fostamatinib 150 mg | Experimental | Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks Receives: Drug: Fostamatinib 150 mg bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin response
Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin
Measured: by Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startJul 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Warm Antibody Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rigel Pharmaceuticals, Study director, Rigel Pharmaceuticals,Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612558
- Sponsor's protocol ID
- C-935788-053
- Acronym
- SOAR
- Status last verified
- Jul 2021
- First submitted
- 19 Nov 2015
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuter DJ, Rogers KA, Boxer MA, Choi M, Agajanian R, Arnold DM, Broome CM, Field JJ, Murakhovskaya I, Numerof R, Tong S. Fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia: Phase 2, multicenter, open-label study. Am J Hematol. 2022 Jun 1;97(6):691-699. doi: 10.1002/ajh.26508. Epub 2022 Mar 3.
PubMed 35179251
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT02612558
- Acronym / sponsor ID
- SOAR / C-935788-053
- Keywords
- Warm antibody autoimmune hemolytic anemia (AIHA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fostamatinib 150 mg | Experimental | Drug: Fostamatinib 150 mg bidFostamatinib 150 mg bid (morning and evening) over the course of 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject must have had a diagnosis of primary or secondary warm antibody AIHA.
- Must have failed at least 1 prior treatment regimen for AIHA.
Key exclusion criteria (4 listed)
- Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria.
- Subject with a platelet count of < 30,000/μL.
- Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.
- Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fostamatinib 150 mg bidAlso: R935788, R788, Fostamatinib, TavalisseFostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed. | Drug | Fostamatinib 150 mg |
Primary outcome
Hemoglobin response
Time frame: by Week 24
Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Derived from this study: PubMed 35179251Kuter DJ, Rogers KA, Boxer MA, Choi M, Agajanian R, Arnold DM, Broome CM, Field JJ, Murakhovskaya I, Numerof R, Tong S. Fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia: Phase 2, multicenter, open-label study. Am J Hematol. 2022 Jun 1;97(6):691-699. doi: 10.1002/ajh.26508. Epub 2022 Mar 3.
- www.aihastudy.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rigel Pharmaceuticals study director
Rigel Pharmaceuticals,Inc.
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fostamatinib 150 mg bid in people with Warm Antibody Autoimmune Hemolytic Anemia, run by Rigel Pharmaceuticals at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin response (time frame: by Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02612558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.