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Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP) (LUNA 3)

Primary Purpose

Immune Thrombocytopenia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rilzabrutinib
Placebo
Sponsored by
Principia Biopharma, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients will be male and female with primary ITP with duration of >6 months in pediatric participants aged 12 to <18 years (pediatric participants aged 10 to <12 years will be enrolled in the EU [EEA countries] only) and duration of >3 months in ages 18 years and above
  2. Patients who had a response (achievement of platelet count ≥50,000/µL) to IVIg/anti-D or CSs that was not sustained and who have documented intolerance, insufficient response or any contra-indication to any appropriate courses of standard of care ITP therapy

  3. An average of 2 platelet counts at least 5 days apart of <30,000/µL during the Screening period, and no single platelet count >35,000/µL within 14 days prior to the first dose of study drug

    - Pediatric patients must additionally be determined to need treatment for ITP as per clinical assessment by the Investigator.

  4. Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5 X 10^9/L, AST/ALT ≤1.5 x upper limit of normal [ULN], albumin ≥3 g/dL, total bilirubin ≤1.5 x ULN [unless the patient has documented Gilbert syndrome], glomerular filtration rate >50 [Cockcroft and Gault method])
  5. Hemoglobin >9 g/dL within 1 week prior to Study Day 1
  6. All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  7. Patients must be able to provide written informed consent or informed assent with corresponding informed consent obtained from the patient's guardian and agree to the schedule of assessments

Exclusion Criteria:

  1. Patients with secondary ITP
  2. Pregnant or lactating women
  3. History (within 5 years of Study Day 1) or current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the study, with the exception of non melanoma skin cancer
  4. Transfusion with blood, blood products, plasmapheresis, or use of any other rescue medications with intent to increase platelet count within 14 days before Study Day 1
  5. Change in CS and/or TPO-RA dose within 14 days prior to Study Day 1 (more than 10% variation from current doses)
  6. Immunosuppressant drugs other than CSs within 5 times the elimination half-life of the drug or 14 days of Study Day 1, whichever is longer

  7. Treatment with rituximab or splenectomy within the 3 months prior to Study Day 1

    - Patients treated with rituximab will have normal B-cell counts prior to enrollment

  8. Has received any investigational drug within the 30 days before receiving the first dose of study medication, or at least 5 times elimination half-life of the drug (whichever is longer); patient should not be using an investigational device at the time of dosing

    • Patients who previously received treatment with Bruton's Tyrosine Kinase (BTK) inhibitors (except rilzabrutinib) within 30 days before the first dose of study drug are not eligible
    • Patients who previously received rilzabrutinib at any time are not eligible
  9. History of solid organ transplant
  10. Myelodysplastic syndrome
  11. Live vaccine within 28 days prior to Study Day 1 or plan to receive one during the study
  12. Planned surgery in the time frame of the dosing period

Sites / Locations

  • University of Southern California_Investigational Site Number 84024Recruiting
  • UCSF Benioff Children's Hospital San Francisco_Investigational Site Number 84020Recruiting
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center_Investigational Site Number 84037Recruiting
  • The Oncology Institute of Hope and Innovation_Investigational Site Number 84031Recruiting
  • Children's Hospital Colorado_Investigational Site Number 84025Recruiting
  • IMMUNOe International Research Centers_Investigational Site Number 84028Recruiting
  • ASCLEPES Research Centers_Investigational Site Number 84023Recruiting
  • Children's Healthcare of Atlanta_Investigational Site Number 84034Recruiting
  • Rush University Medical Center_Investigational Site Number 84029Recruiting
  • University of Louisville - James Graham Brown Cancer Center_Investigational Site Number 84033Recruiting
  • Montefiore Medical Center_Investigational Site Number 84032Recruiting
  • Cleveland Clinic_Investigational Site Number 84026Recruiting
  • The Children's Hospital of Philadelphia (CHOP)_Investigational Site Number 84027Recruiting
  • University of Utah-Huntsman Cancer Institute_Investigational Site Number 84035Recruiting
  • Investigational Site Number 03206Recruiting
  • Investigational Site Number 03205Recruiting
  • Investigational Site Number 03209Recruiting
  • Investigational Site Number 03208Recruiting
  • Investigational Site Number 03609Recruiting
  • Investigational Site Number 03606Recruiting
  • Investigational Site Number 03607Recruiting
  • Investigational Site Number 03610Recruiting
  • Investigational Site Number 03611Recruiting
  • Investigational Site Number 03608Recruiting
  • Investigational Site Number 04005Recruiting
  • Investigational Site Number 04004Recruiting
  • Investigational Site Number 04001Recruiting
  • Investigational Site Number 04003Recruiting
  • Investigational Site Number 04002Recruiting
  • Investigational Site Number 07606Recruiting
  • Investigational Site Number 07610Recruiting
  • Investigational Site Number 07605Recruiting
  • Investigational Site Number 07609Recruiting
  • Investigational Site Number 07608Recruiting
  • Investigational Site Number 07607Recruiting
  • Investigational Site Number 07611Recruiting
  • CHU Sainte-Justine_Investigational site number 12405Recruiting
  • Investigational Site Number 15201Recruiting
  • Investigational Site Number 15204Recruiting
  • Investigational Site Number 15202Recruiting
  • Wuhan Union Hospital of Tongji Medical College of HUST - Investigational Site Number: 15601Recruiting
  • Shengjing Hospital of China Medical University - Investigational Site Number: 15603Recruiting
  • Shaanxi Provincial People's Hospital - Investigational Site Number: 15607Recruiting
  • Qilu Hospital of Shandong University - Investigational Site Number: 15605Recruiting
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences - Investigational Site Number: 15602Recruiting
  • Second Affiliated Hospital of Kunming Medical University - Investigational Site Number: 15604Recruiting
  • Investigational Site Number 25011Recruiting
  • Investigational Site Number 25010Recruiting
  • Investigational Site Number 25009Recruiting
  • Investigational Site Number 25008Recruiting
  • Investigational Site Number 25012Recruiting
  • Investigational Site Number 25007Recruiting
  • Investigational Site Number 27610Recruiting
  • Investigational Site Number 27612Recruiting
  • Investigational Site Number 27613Recruiting
  • Investigational Site Number 27611Recruiting
  • Investigational Site Number 34803Recruiting
  • Investigational Site Number 34805Recruiting
  • Investigational Site Number 34801Recruiting
  • Investigational Site Number 34804Recruiting
  • Investigational Site Number 34802Recruiting
  • Investigational Site Number 37605Recruiting
  • Investigational Site Number 37606Recruiting
  • Investigational Site Number 37607Recruiting
  • Investigational Site Number 37608Recruiting
  • Investigational Site Number 37609Recruiting
  • Investigational Site Number 38012Recruiting
  • Investigational Site Number 38014Recruiting
  • Investigational Site Number 38013Recruiting
  • Investigational Site Number 38015Recruiting
  • Investigational Site Number 38010Recruiting
  • Investigational Site Number 38011Recruiting
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital - Investigational Site Number: 39203Recruiting
  • Ishikawa Prefectural Central Hospital - Investigational Site Number: 39205Recruiting
  • Osaka University Hospital - Investigational Site Number: 39202Recruiting
  • Kitasato University Hospital - Investigational Site Number: 39207Recruiting
  • Local Incorporated Administrative Institution Saitama prefectural hospital organization Saitama prefectural Children's Medical Center - Investigational Site Number: 39206Recruiting
  • Saitama Medical University Hospital - Investigational Site Number: 39201Recruiting
  • The University of Tokyo Hospital - Investigational Site Number: 39208Recruiting
  • Tokyo Metropolitan Bokutoh Hospital - Investigational Site Number: 39209Recruiting
  • National Hospital Organization Tokyo Medical Center - Investigational Site Number: 39210Recruiting
  • National Center for Child Health and Development - Investigational Site Number: 39204Recruiting
  • Investigational Site Number 41004Recruiting
  • Investigational Site Number 41001Recruiting
  • Investigational Site Number 41003Recruiting
  • Investigational Site Number 41005Recruiting
  • Investigational Site Number 41006Recruiting
  • Investigational Site Number 48402Recruiting
  • Investigational Site Number 48406Recruiting
  • Investigational Site Number 48405Recruiting
  • Investigational Site Number 48404Recruiting
  • Investigational Site Number 48401Recruiting
  • Investigational Site Number 48403Recruiting
  • Erasmus MC_Investigational Site Number 52801Recruiting
  • Investigational Site Number 57802Recruiting
  • Investigational Site Number 57801Recruiting
  • Investigational Site Number 61615Recruiting
  • Investigational Site Number 61617Recruiting
  • Investigational Site Number 61609Recruiting
  • Investigational Site Number 61612Recruiting
  • Investigational Site Number 64307Recruiting
  • Investigational Site Number 64305Recruiting
  • Investigational Site Number 64304Recruiting
  • Investigational Site Number 64301Recruiting
  • Investigational Site Number 64302Recruiting
  • Investigational Site Number 64306Recruiting
  • Investigational Site Number 64303Recruiting
  • Investigational Site Number 70201Recruiting
  • Investigational Site Number 70202Recruiting
  • Investigational Site Number 70203Recruiting
  • Investigational Site Number 72409Recruiting
  • Investigational Site Number 72410Recruiting
  • Investigational Site Number 72412Recruiting
  • Investigational Site Number 72408Recruiting
  • Investigational Site Number 72411Recruiting
  • Investigational Site Number 72413Recruiting
  • Investigational Site Number 72407Recruiting
  • Investigational Site Number 76405Recruiting
  • Investigational Site Number 76404Recruiting
  • Investigational Site Number 76402Recruiting
  • Investigational Site Number 76401Recruiting
  • Investigational Site Number 76403Recruiting
  • Investigational Site Number 79208Recruiting
  • Investigational Site Number 79210Recruiting
  • Investigational Site Number 79206Recruiting
  • Investigational Site Number 79209Recruiting
  • Investigational Site Number 80408Recruiting
  • Investigational Site Number 80409Recruiting
  • Investigational Site Number 80410Recruiting
  • Investigational Site Number 82605Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rilzabrutinib

Placebo

Arm Description

Patients receive rilzabrutinib 400mg orally twice daily for up to 24 weeks followed by 28 weeks of open label period

Patients receive matching placebo 400mg orally twice daily for up to 24 weeks

Outcomes

Primary Outcome Measures

Durable platelet response during the last 6 weeks of the 24-week blinded treatment period (not for EU and UK)
Durable platelet response is defined as a proportion of participants able to achieve platelet counts at or above 50,000/μL for ≥ two-thirds of at least 8 non-missing weekly scheduled platelet measurements during the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy, provided that at least 2 non-missing weekly scheduled platelet measurements are at or above 50,000/μL.
for EU and UK: Proportion of adult participants able to achieve platelet counts at or above 50,000/μL for at least 8 out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy

Secondary Outcome Measures

Number of weeks with platelet count ≥50,000/μL OR between ≥30,000/μL and <50,000/μL and at least doubled from baseline over the 24-week blinded treatment period in the absence of rescue therapy
Number of weeks with platelet counts ≥30,000/μL and at least doubled from baseline over the 24-week blinded treatment period in the absence of rescue therapy
Time to first platelet count of ≥50,000/μL OR between ≥30,000/μL and <50,000/μL and doubled from baseline
Proportion of patients requiring rescue therapy during the 24-week blinded treatment period
Change from baseline on Item 10 of the ITP-Patient Assessment Questionnaire in adult patients (≥18 years) at Week 13
for EU and UK: Change from baseline in Idiopathic Thrombocytopenic Purpura Bleeding Scale (IBLS) assessment at Week 25
Proportion of participants who able to achieve stable platelet response, within a period of 24 weeks following initial achievement of the platelet response
Stable platelet response is defined as no 2 scheduled visits, at least 4 weeks apart, with a platelet count less than 50,000/µL, without an intervening visit with a platelet count ≥50,000/µL. Initial platelet response defined as platelet count ≥50,000/μL within 12 weeks of initiation of treatment with rilzabrutinib during the study.
Frequency and severity of Treatment Emergent Adverse Events
Including physical examination, ECG, clinical laboratory test results, vital signs and laboratory tests (serum chemistry, hematology, except for platelet counts included in the primary efficacy endpoint)
Frequency and severity of bleeding TEAEs
Plasma concentrations of rilzabrutinib
Change from baseline on the Symptoms, Bother and Activity domains of the ITP Patient Assessment Questionnaire (ITP-PAQ) in adult patients (≥18 years)
The ITP Patient Assessment Questionnaire™ (ITP-PAQ™) is a disease-specific instrument that was designed to measure the Quality of Life (QoL) of adult patients with immune thrombocytopenia. The items employ a 4-week recall with responses recorded on 4-, 5- or 7-point Likert scales. All item scores are transformed to a 0 to 100 continuum where higher scores represent better QoL and are weighted equally to derive the scale scores.
Change from baseline in disease-specific QoL as measured by the Kids' ITP Tools (ITP-KIT) score in pediatric participants
The ITP-KIT include a battery of three disease-specific instruments, a child self-report form designed to be completed by children ≥7 years, a parent proxy report form for children <7 and a parent impact form. Respondents record their disease experience based on a 1-week recall. The instrument yields a total score which is the summation of the items converted to a 0 to 100 score with higher scores indicating better disease-specific QoL.

Full Information

First Posted
September 18, 2020
Last Updated
September 15, 2023
Sponsor
Principia Biopharma, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT04562766
Brief Title
Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
Acronym
LUNA 3
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Principia Biopharma, a Sanofi Company

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
This is a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients will receive rilzabrutinib or placebo 400mg twice daily. For each patient, the study will last up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This includes Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up. Patients who respond per specified criteria at the end of the Open-Label Period will be able to enter the Long-Term Extension (LTE) where they will continue to receive treatment until the last patient who enters the LTE has completed 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rilzabrutinib
Arm Type
Experimental
Arm Description
Patients receive rilzabrutinib 400mg orally twice daily for up to 24 weeks followed by 28 weeks of open label period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive matching placebo 400mg orally twice daily for up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
Rilzabrutinib
Other Intervention Name(s)
PRN1008
Intervention Description
400mg Caplet
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PRN1008 Placebo
Intervention Description
400mg Caplet
Primary Outcome Measure Information:
Title
Durable platelet response during the last 6 weeks of the 24-week blinded treatment period (not for EU and UK)
Description
Durable platelet response is defined as a proportion of participants able to achieve platelet counts at or above 50,000/μL for ≥ two-thirds of at least 8 non-missing weekly scheduled platelet measurements during the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy, provided that at least 2 non-missing weekly scheduled platelet measurements are at or above 50,000/μL.
Time Frame
24 weeks
Title
for EU and UK: Proportion of adult participants able to achieve platelet counts at or above 50,000/μL for at least 8 out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Number of weeks with platelet count ≥50,000/μL OR between ≥30,000/μL and <50,000/μL and at least doubled from baseline over the 24-week blinded treatment period in the absence of rescue therapy
Time Frame
24 weeks
Title
Number of weeks with platelet counts ≥30,000/μL and at least doubled from baseline over the 24-week blinded treatment period in the absence of rescue therapy
Time Frame
24 weeks
Title
Time to first platelet count of ≥50,000/μL OR between ≥30,000/μL and <50,000/μL and doubled from baseline
Time Frame
24 weeks
Title
Proportion of patients requiring rescue therapy during the 24-week blinded treatment period
Time Frame
24 weeks
Title
Change from baseline on Item 10 of the ITP-Patient Assessment Questionnaire in adult patients (≥18 years) at Week 13
Time Frame
From baseline to Week 13
Title
for EU and UK: Change from baseline in Idiopathic Thrombocytopenic Purpura Bleeding Scale (IBLS) assessment at Week 25
Time Frame
At Week 25
Title
Proportion of participants who able to achieve stable platelet response, within a period of 24 weeks following initial achievement of the platelet response
Description
Stable platelet response is defined as no 2 scheduled visits, at least 4 weeks apart, with a platelet count less than 50,000/µL, without an intervening visit with a platelet count ≥50,000/µL. Initial platelet response defined as platelet count ≥50,000/μL within 12 weeks of initiation of treatment with rilzabrutinib during the study.
Time Frame
24 weeks
Title
Frequency and severity of Treatment Emergent Adverse Events
Description
Including physical examination, ECG, clinical laboratory test results, vital signs and laboratory tests (serum chemistry, hematology, except for platelet counts included in the primary efficacy endpoint)
Time Frame
52 weeks of treatment, 12 months of long term extension and 4 weeks of follow up post last dose
Title
Frequency and severity of bleeding TEAEs
Time Frame
52 weeks of treatment, 12 months of long term extension and 4 weeks of follow up post last dose
Title
Plasma concentrations of rilzabrutinib
Time Frame
Until 52 weeks
Title
Change from baseline on the Symptoms, Bother and Activity domains of the ITP Patient Assessment Questionnaire (ITP-PAQ) in adult patients (≥18 years)
Description
The ITP Patient Assessment Questionnaire™ (ITP-PAQ™) is a disease-specific instrument that was designed to measure the Quality of Life (QoL) of adult patients with immune thrombocytopenia. The items employ a 4-week recall with responses recorded on 4-, 5- or 7-point Likert scales. All item scores are transformed to a 0 to 100 continuum where higher scores represent better QoL and are weighted equally to derive the scale scores.
Time Frame
52 weeks of treatment, 12 months of long term extension and 4 weeks of follow up post last dose
Title
Change from baseline in disease-specific QoL as measured by the Kids' ITP Tools (ITP-KIT) score in pediatric participants
Description
The ITP-KIT include a battery of three disease-specific instruments, a child self-report form designed to be completed by children ≥7 years, a parent proxy report form for children <7 and a parent impact form. Respondents record their disease experience based on a 1-week recall. The instrument yields a total score which is the summation of the items converted to a 0 to 100 score with higher scores indicating better disease-specific QoL.
Time Frame
52 weeks of treatment, 12 months of long term extension and 4 weeks of follow up post last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be male and female with primary ITP with duration of >6 months in pediatric participants aged 12 to <18 years (pediatric participants aged 10 to <12 years will be enrolled in the EU [EEA countries] only) and duration of >3 months in ages 18 years and above Patients who had a response (achievement of platelet count ≥50,000/µL) to IVIg/anti-D or CSs that was not sustained and who have documented intolerance, insufficient response or any contra-indication to any appropriate courses of standard of care ITP therapy An average of 2 platelet counts at least 5 days apart of <30,000/µL during the Screening period, and no single platelet count >35,000/µL within 14 days prior to the first dose of study drug - Pediatric patients must additionally be determined to need treatment for ITP as per clinical assessment by the Investigator. Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5 X 10^9/L, AST/ALT ≤1.5 x upper limit of normal [ULN], albumin ≥3 g/dL, total bilirubin ≤1.5 x ULN [unless the patient has documented Gilbert syndrome], glomerular filtration rate >50 [Cockcroft and Gault method]) Hemoglobin >9 g/dL within 1 week prior to Study Day 1 All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Patients must be able to provide written informed consent or informed assent with corresponding informed consent obtained from the patient's guardian and agree to the schedule of assessments Exclusion Criteria: Patients with secondary ITP Pregnant or lactating women History (within 5 years of Study Day 1) or current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the study, with the exception of non melanoma skin cancer Transfusion with blood, blood products, plasmapheresis, or use of any other rescue medications with intent to increase platelet count within 14 days before Study Day 1 Change in CS and/or TPO-RA dose within 14 days prior to Study Day 1 (more than 10% variation from current doses) Immunosuppressant drugs other than CSs within 5 times the elimination half-life of the drug or 14 days of Study Day 1, whichever is longer Treatment with rituximab or splenectomy within the 3 months prior to Study Day 1 - Patients treated with rituximab will have normal B-cell counts prior to enrollment Has received any investigational drug within the 30 days before receiving the first dose of study medication, or at least 5 times elimination half-life of the drug (whichever is longer); patient should not be using an investigational device at the time of dosing Patients who previously received treatment with Bruton's Tyrosine Kinase (BTK) inhibitors (except rilzabrutinib) within 30 days before the first dose of study drug are not eligible Patients who previously received rilzabrutinib at any time are not eligible History of solid organ transplant Myelodysplastic syndrome Live vaccine within 28 days prior to Study Day 1 or plan to receive one during the study Planned surgery in the time frame of the dosing period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Facility Information:
Facility Name
University of Southern California_Investigational Site Number 84024
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Duran
Phone
323-865-0371
Email
duran_c@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Howard Liebman
Facility Name
UCSF Benioff Children's Hospital San Francisco_Investigational Site Number 84020
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susannah Lim
Phone
415-390-5625
Email
Susannah.Lim@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Kristin Shimano
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center_Investigational Site Number 84037
City
Torrance
State/Province
California
ZIP/Postal Code
00000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Tomassetti
Phone
424-306-8223
Email
sarah.tomassetti@lundquist.org
First Name & Middle Initial & Last Name & Degree
Sarah Tomassetti
Facility Name
The Oncology Institute of Hope and Innovation_Investigational Site Number 84031
City
Whittier
State/Province
California
ZIP/Postal Code
00000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Bettino
Phone
562-693-4477
Email
kbettino@airesearch.us
First Name & Middle Initial & Last Name & Degree
Amitabha Mazumder
Facility Name
Children's Hospital Colorado_Investigational Site Number 84025
City
Aurora
State/Province
Colorado
ZIP/Postal Code
00000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew McClung
Phone
720-777-8190
Email
matthew.mcclung@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Taizo Nakano
Facility Name
IMMUNOe International Research Centers_Investigational Site Number 84028
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Tafoya
Phone
303-771-9000
Email
ltafoya@immunoe.com
First Name & Middle Initial & Last Name & Degree
Isaac Melamed, MD
Facility Name
ASCLEPES Research Centers_Investigational Site Number 84023
City
Weeki Wachee
State/Province
Florida
ZIP/Postal Code
34607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Leonard
Phone
352-364-9401
Email
kleonard@asclepes.com
First Name & Middle Initial & Last Name & Degree
Daniel Kerr
Facility Name
Children's Healthcare of Atlanta_Investigational Site Number 84034
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
00000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle Dean
Phone
404-785-8700
Email
gabrielle.dean@choa.org
First Name & Middle Initial & Last Name & Degree
Carolyn Bennett
Facility Name
Rush University Medical Center_Investigational Site Number 84029
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josephine Volgi
Phone
312-942-7902
Email
Josephine_R_Volgi@rush.edu
First Name & Middle Initial & Last Name & Degree
Lisa Boggio
Facility Name
University of Louisville - James Graham Brown Cancer Center_Investigational Site Number 84033
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
00000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamila Cisak
Phone
502-852-7106
Email
kamila.cisak@louisville.edu
First Name & Middle Initial & Last Name & Degree
Kamila Cisak, MD
Facility Name
Montefiore Medical Center_Investigational Site Number 84032
City
Bronx
State/Province
New York
ZIP/Postal Code
00000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noelle Townsend
Phone
718-430-2377
Email
noelle.townsend@einsteinmed.edu
First Name & Middle Initial & Last Name & Degree
Irina Murakhovskaya
Facility Name
Cleveland Clinic_Investigational Site Number 84026
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Wilson
Phone
216-392-7875
Email
wilsona3@ccf.org
First Name & Middle Initial & Last Name & Degree
Alan Lichtin
Facility Name
The Children's Hospital of Philadelphia (CHOP)_Investigational Site Number 84027
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abinaya Arulselvan
Phone
215-590-5476
Email
ARULSELVAA@chop.edu
First Name & Middle Initial & Last Name & Degree
Michele Lambert
Facility Name
University of Utah-Huntsman Cancer Institute_Investigational Site Number 84035
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
00000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mouhamed Yazan Abou-Ismail
Phone
801-213-1203
Email
Yazan.Abou-Ismail@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Mouhamed Yazan Abou-Ismail, MD
Facility Name
Investigational Site Number 03206
City
Capital Federal
ZIP/Postal Code
C1280AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 03205
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 03209
City
Corrientes
ZIP/Postal Code
W3410FND
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 03208
City
San Juan
ZIP/Postal Code
J5402DIL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 03609
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 03606
City
Frankston
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 03607
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 03610
City
Perth
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 03611
City
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 03608
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 04005
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 04004
City
Leoben
ZIP/Postal Code
8700
Country
Austria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 04001
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 04003
City
Steyr
ZIP/Postal Code
24204
Country
Austria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 04002
City
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 07606
City
Belem Do Para
ZIP/Postal Code
66053-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 07610
City
Cascavel
ZIP/Postal Code
85806-300
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 07605
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 07609
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 07608
City
Salvador
ZIP/Postal Code
V
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 07607
City
Sao Paulo
ZIP/Postal Code
04039-004
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 07611
City
São Paulo
ZIP/Postal Code
08270-070
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CHU Sainte-Justine_Investigational site number 12405
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bianka Courcelle
Phone
514-345-4931
Ext
3757
Email
bianka.courcelle.hsj@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Guillaume Leblanc
Email
guillaume.leblanc.hsj@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Yves Pastore
Facility Name
Investigational Site Number 15201
City
La Serena
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 15204
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 15202
City
Viña Del Mar
ZIP/Postal Code
322000
Country
Chile
Individual Site Status
Recruiting
Facility Name
Wuhan Union Hospital of Tongji Medical College of HUST - Investigational Site Number: 15601
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Hu
Email
dr_huyu@126.com
First Name & Middle Initial & Last Name & Degree
Yu Hu
Facility Name
Shengjing Hospital of China Medical University - Investigational Site Number: 15603
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuogang Liu
Phone
+86 189 4025 1010
Email
liuzg@sj-hopital.org
First Name & Middle Initial & Last Name & Degree
Zhuogang Liu
Facility Name
Shaanxi Provincial People's Hospital - Investigational Site Number: 15607
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
30012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Wang
Phone
+86 13 5719 36193
Email
13571936193@163.com
First Name & Middle Initial & Last Name & Degree
Yi Wang
Facility Name
Qilu Hospital of Shandong University - Investigational Site Number: 15605
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuyi Yang
Email
yuyi.yang@tigermedgrp.com
First Name & Middle Initial & Last Name & Degree
Ming Hou
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences - Investigational Site Number: 15602
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shumin Wang
Email
shumin.wang@tigermedgrp.com
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Facility Name
Second Affiliated Hospital of Kunming Medical University - Investigational Site Number: 15604
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650101
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeping Zhou
Phone
86 871-6340-2359
Email
zhouzeping@kmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Zeping Zhou
Facility Name
Investigational Site Number 25011
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 25010
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 25009
City
Nantes Cedex
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 25008
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 25012
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 25007
City
Pessac
ZIP/Postal Code
33064
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 27610
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 27612
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 27613
City
Frankfurt am Main
ZIP/Postal Code
D-60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 27611
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 34803
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 34805
City
Debrecen
ZIP/Postal Code
V
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 34801
City
Győr
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 34804
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 34802
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 37605
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 37606
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 37607
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 37608
City
Tel HaShomer
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 37609
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 38012
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 38014
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 38013
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 38015
City
Rome
ZIP/Postal Code
000168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 38010
City
Trieste
ZIP/Postal Code
34125
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 38011
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital - Investigational Site Number: 39203
City
Hiroshima City
ZIP/Postal Code
730-8619
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megumi Murakami
Phone
+81-82-297-5700
Email
murakami.megumi@neues.co.jp
First Name & Middle Initial & Last Name & Degree
Shinya Katsutani
Facility Name
Ishikawa Prefectural Central Hospital - Investigational Site Number: 39205
City
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariko Nishita
Phone
+81-80-1086-3843
Email
nishita.mariko@neues.co.jp
First Name & Middle Initial & Last Name & Degree
Masaki Yamaguchi
Facility Name
Osaka University Hospital - Investigational Site Number: 39202
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saki Terada
Phone
+81 6-6879-5111
Email
terada.saki318@eps.co.jp
First Name & Middle Initial & Last Name & Degree
Hirokazu Kashiwagi
Facility Name
Kitasato University Hospital - Investigational Site Number: 39207
City
Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuko Minowa
Phone
+81-42-778-8111
Email
k-minowa@kitasato-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Takahiro Suzuki
Facility Name
Local Incorporated Administrative Institution Saitama prefectural hospital organization Saitama prefectural Children's Medical Center - Investigational Site Number: 39206
City
Saitama-shi
ZIP/Postal Code
330-8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoko Kozawa
Phone
+81-48-601-2200
Email
kozawa.naoko755@eps.co.jp
First Name & Middle Initial & Last Name & Degree
Katsuyoshi Koh
Facility Name
Saitama Medical University Hospital - Investigational Site Number: 39201
City
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshiko Asami
Phone
+81-49-276-2019
Email
yo_asami@saitama-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Yoshitaka Miyakawa
Facility Name
The University of Tokyo Hospital - Investigational Site Number: 39208
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miki Suwa
Phone
+81-3-3264-3345
Email
miki-suwa@iromgroup.co.jp
First Name & Middle Initial & Last Name & Degree
Mineo Kurokawa
Facility Name
Tokyo Metropolitan Bokutoh Hospital - Investigational Site Number: 39209
City
Tokyo
ZIP/Postal Code
130-8575
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuyo Horikiri
Email
horikiri.yasuyo330@eps.co.jp
First Name & Middle Initial & Last Name & Degree
Nobuharu Kosugi
Facility Name
National Hospital Organization Tokyo Medical Center - Investigational Site Number: 39210
City
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuri Hashizumi
Phone
+81-3-3411-2526
Email
yuri.hashizumi@kankakuki.jp
First Name & Middle Initial & Last Name & Degree
Hironori Ueno
Facility Name
National Center for Child Health and Development - Investigational Site Number: 39204
City
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sora Nazuka
Phone
81-3-5494-7120
Email
nazuka-s@ncchd.go.jp
First Name & Middle Initial & Last Name & Degree
Akira Ishiguro
Facility Name
Investigational Site Number 41004
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 41001
City
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 41003
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 41005
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 41006
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 48402
City
Chihuahua
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 48406
City
Ciudad de mexico
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 48405
City
Distrito Federal
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 48404
City
Durango
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 48401
City
Monterrey
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 48403
City
Zapopan
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Erasmus MC_Investigational Site Number 52801
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith van Eeuwijk
Phone
+31 (0)10 70 35392
Email
j.vaneeuwijk@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Jansen Gerard
Facility Name
Investigational Site Number 57802
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 57801
City
Grålum
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 61615
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 61617
City
Piła
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 61609
City
Słupsk
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 61612
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 64307
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 64305
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 64304
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 64301
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 64302
City
Saint Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 64306
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 64303
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 70201
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 70202
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 70203
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 72409
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 72410
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 72412
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 72408
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 72411
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 72413
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 72407
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 76405
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 76404
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 76402
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 76401
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 76403
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 79208
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 79210
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 79206
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 79209
City
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 80408
City
Dnipropetrovs'k
ZIP/Postal Code
49102
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 80409
City
Kryvyi Rih
ZIP/Postal Code
50025
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 80410
City
Kyiv
ZIP/Postal Code
3143
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Investigational Site Number 82605
City
Norfolk
ZIP/Postal Code
Norfolk
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

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