A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

March 2, 2022 updated by: Rigel Pharmaceuticals

The primary objective of this study is:

• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4201
        • Princess Alexandra Hospital - Cancer Trials Unit
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Austria
      • Vienna, Austria, 1140
        • Hanusch-Krankenhaus
      • Wien, Austria, A-1090
        • Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie
  • Belarus
      • Vitebsk, Belarus, 210037
        • Vitebsk Regional Clinical Hospital
      • Vitebsk, Belarus, 210603
        • Vitebsk Regional Clinical Oncology Dispensary
  • Belgium
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolaas
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology
      • Sofia, Bulgaria, 1431
        • University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology
      • Sofia, Bulgaria, 1756
        • Specialized Hospital for Active Treatment of Hematological Disease EAD,
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika
      • Ostrava, Czechia, 70852
        • Fakultni nemocnice Ostrava Klinika hematoonkologie
  • France
      • Pessac, France, 33603
        • CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses
  • Georgia
      • Tbilisi, Georgia, 0186
        • LTD Multiprofile Clinic Consilium Medulla
      • Tbilisi, Georgia, 0186
        • M. Zodelava Hematology Centre, Tbilisi
  • Germany
      • Essen, Germany, 45147
        • Universitatsklinikum Essen
  • Italy
      • Milan, Italy
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia
      • Novara, Italy, 28100
        • SCDU Ematologia AOU "Maggiore della Carità"
  • Netherlands
      • Amsterdam, Netherlands
        • Academisch Medisch Centrum
  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital
  • Russian Federation
      • Moscow, Russian Federation, 125167
        • National Research Center for Hematology
      • Sochi, Russian Federation, 354057
        • State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
  • Serbia
      • Novi Sad, Serbia, 21000
        • Clinical Centre of Vojvodina, Clinic for Hematology
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
  • Ukraine
      • Dnipro, Ukraine, 49102
        • City Clinical Hospital № 4, Hematology Center
      • Kyiv, Ukraine, 04112
        • Kyiv City Clinical Hospital №9, hematology department №1
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory
      • Torrance, California, United States, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Comprehensive Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • John Hopkins Bayview Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • Washington
      • Olympia, Washington, United States, 98506
        • American Oncology Network Vista Oncology Division
      • Seattle, Washington, United States, 98109
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures.
  2. Subject must have completed all 24 weeks of participation in the study C-935788-057.

Exclusion Criteria:

1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fostamatinib

Subjects who at any time during the C-935788-057 study achieved a hemoglobin response will continue at their dose and regimen from the Week 22 visit in the C-935788-057 study.

All other subjects who enter the extension study will initially receive fostamatinib 100 mg PO bid. Starting at Week 4, the initial fostamatinib dose of 100 mg PO bid will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug, based on the Investigator's judgment.
Drug: Fostamatinib disodium
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
Other Names:
  • R935788
  • Fostamatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 104 weeks
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
104 weeks
Blood Pressure
Time Frame: 104 weeks
Change from baseline in blood pressure over time
104 weeks
Absolute Neutrophil Count (ANC)
Time Frame: 104 weeks
Change from baseline in absolute neutrophil count (ANC) over time
104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of Durable Hemoglobin Response
Time Frame: 24 weeks
24 weeks
Total Duration of Response
Time Frame: During the Intervention period up to 104 weeks
During the Intervention period up to 104 weeks
Corticosteroid dose
Time Frame: During the Intervention period up to 104 weeks
Net cumulative change from Baseline in corticosteroid dose
During the Intervention period up to 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigel Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2019

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-935788-058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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