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

Primary Purpose

Warm Antibody Autoimmune Hemolytic Anemia

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fostamatinib disodium
Sponsored by
Rigel Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warm Antibody Autoimmune Hemolytic Anemia focused on measuring wAIHA, Warm Antibody Autoimmune Hemolytic Anemia, Warm Autoimmune Hemolytic Anemia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Lombardi Comprehensive Cancer Center
  • John Hopkins Bayview Medical Center
  • Massachusetts General Hospital
  • Comprehensive Cancer Centers of Nevada
  • American Oncology Network Vista Oncology Division
  • University of Washington
  • Princess Alexandra Hospital - Cancer Trials Unit
  • The Alfred Hospital
  • Hanusch-Krankenhaus
  • Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie
  • Vitebsk Regional Clinical Hospital
  • Vitebsk Regional Clinical Oncology Dispensary
  • AZ Nikolaas
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology
  • University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology
  • Specialized Hospital for Active Treatment of Hematological Disease EAD,
  • Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika
  • Fakultni nemocnice Ostrava Klinika hematoonkologie
  • CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses
  • LTD Multiprofile Clinic Consilium Medulla
  • M. Zodelava Hematology Centre, Tbilisi
  • Universitätsklinikum Essen
  • Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia
  • SCDU Ematologia AOU "Maggiore della Carità"
  • Academisch Medisch Centrum
  • Haukeland University Hospital
  • National Research Center for Hematology
  • State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
  • Clinical Centre of Vojvodina, Clinic for Hematology
  • Hospital Vall d'Hebron
  • Hospital Clinic de Barcelona
  • City Clinical Hospital № 4, Hematology Center
  • Kyiv City Clinical Hospital №9, hematology department №1
  • Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fostamatinib

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Achievement of Durable Hemoglobin Response
Total Duration of Response
Corticosteroid dose
Net cumulative change from Baseline in corticosteroid dose

Full Information

First Posted
October 23, 2019
Last Updated
March 2, 2022
Sponsor
Rigel Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04138927
Brief Title
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Official Title
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is: • To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warm Antibody Autoimmune Hemolytic Anemia
Keywords
wAIHA, Warm Antibody Autoimmune Hemolytic Anemia, Warm Autoimmune Hemolytic Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fostamatinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fostamatinib disodium
Other Intervention Name(s)
R935788, Fostamatinib
Intervention Description
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
Time Frame
104 weeks
Title
Blood Pressure
Description
Change from baseline in blood pressure over time
Time Frame
104 weeks
Title
Absolute Neutrophil Count (ANC)
Description
Change from baseline in absolute neutrophil count (ANC) over time
Time Frame
104 weeks
Secondary Outcome Measure Information:
Title
Achievement of Durable Hemoglobin Response
Time Frame
24 weeks
Title
Total Duration of Response
Time Frame
During the Intervention period up to 104 weeks
Title
Corticosteroid dose
Description
Net cumulative change from Baseline in corticosteroid dose
Time Frame
During the Intervention period up to 104 weeks

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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