Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

Last updated: June 4, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Anemia

Hemoglobinuria, Paroxysmal

Treatment

Placebo

M281

Clinical Study ID

NCT04119050
CR108987
2019-000720-17
2023-505321-14-00
MOM-M281-006
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Participants greater than or equal to (>=)18 years of age

  • Have been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3months, and are currently receiving treatment for wAIHA or have previously receivedtreatment for wAIHA (treatment-naive participants are not eligible)

  • Participants must be able to understand and voluntarily provide written informedconsent to participate in the study and comply with all study procedures

Exclusion

Exclusion criteria:

  • Participants must not be pregnant or breastfeeding

  • Participants must not have other clinically relevant abnormalities currently or intheir history that the Investigator would deem them ineligible to participate

  • Have been diagnosed with cold antibody autoimmune hemolytic anemia (AIHA), coldagglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal coldhemoglobinuria

Study Design

Total Participants: 118
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
August 15, 2019
Estimated Completion Date:
April 01, 2028

Study Description

The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.

Connect with a study center

  • Oncologica do Brasil

    Belem, 66033-720
    Brazil

    Site Not Available

  • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

    Botucatu, 18618-687
    Brazil

    Site Not Available

  • Hospital das Clínicas da Faculdade de Medicina de Botucatu

    Botucatu, 18610-070
    Brazil

    Site Not Available

  • Impar Servicos Hospitalares S/A - Hospital Brasilia

    Brasília, 71681-603
    Brazil

    Site Not Available

  • Impar Servicos Hospitalares S/A - Hospital Brasília

    Brasília, 71681-603
    Brazil

    Site Not Available

  • CTO Centro de Tratamento Oncologico Unidade Belem

    Campinas, 13083-887
    Brazil

    Site Not Available

  • Hospital Das Clinicas Da Universidade Federal De Goias

    Goiânia, 74605-020
    Brazil

    Site Not Available

  • Universidade Federal de Goias - Hospital das Clinicas da UFG

    Goiânia, 74605-020
    Brazil

    Site Not Available

  • Impar Servicos Hospitalares S/A

    Niteroi, 24020-096
    Brazil

    Site Not Available

  • Complexo Hospitalar de Niteroi

    Niterói, 24020-096
    Brazil

    Site Not Available

  • MultiHemo Servicos Medicos S.A

    Recife, 50070-460
    Brazil

    Site Not Available

  • Oncoclinicas - Unidade OC Oncoclinicas Multihemo Ilha do Leite

    Recife, 50040-000
    Brazil

    Site Not Available

  • Clion - Clinica de Oncologia

    Salvador, 40170-010
    Brazil

    Site Not Available

  • Hospital Sao Rafael

    Salvador, 41253 190
    Brazil

    Site Not Available

  • Nucleo de Oncologia da Bahia

    Salvador, 40170-110
    Brazil

    Site Not Available

  • Hospital Sao Rafael

    Salvador 3450554, 41253 190
    Brazil

    Completed

  • Hospital Santa Marcelina

    Santo Andre, 09060-870
    Brazil

    Active - Recruiting

  • CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650
    Brazil

    Site Not Available

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060 650
    Brazil

    Site Not Available

  • Hospital Santa Marcelina

    Santo André, 09060-870
    Brazil

    Site Not Available

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André 3449701, 09060 650
    Brazil

    Completed

  • Centro Integrado de Pesquisa -Hospital de Base de São José do Rio Preto

    Sao Jose Do Rio Preto, 15090-000
    Brazil

    Completed

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

    Sao Jose do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

    Sao Jose do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    Sao Paulo, 05403 000
    Brazil

    Active - Recruiting

  • Hospital Sirio Libanes Sao Paulo

    Sao Paulo, 01308-050
    Brazil

    Active - Recruiting

  • SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

    Sao Paulo, 04037-002
    Brazil

    Site Not Available

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    Sao Paulo, 01308-050
    Brazil

    Active - Recruiting

  • Universidade Federal de Sao Paulo

    Sao Paulo, 04024-002
    Brazil

    Completed

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090 000
    Brazil

    Site Not Available

  • Casa de Saúde Santa Marcelina - Hospital Santa Marcelina

    São Paulo, 08270-070
    Brazil

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    São Paulo, 05403 000
    Brazil

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    São Paulo, 01308-901
    Brazil

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    São Paulo, 01308 050
    Brazil

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    São Paulo, 04024-002
    Brazil

    Site Not Available

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    São Paulo 3448439, 01308 050
    Brazil

    Completed

  • Universidade Federal de Sao Paulo

    São Paulo 3448439, 04024-002
    Brazil

    Completed

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

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    Beijing, 100020
    China

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    Beijing, 100044
    China

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    Beijing 1816670, 100020
    China

    Completed

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    Beijing 1816670, 100044
    China

    Completed

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    Beijing Shi, 100020
    China

    Completed

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    Beijing Shi, 100044
    China

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    Changchun, 130021
    China

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    Chengdu, 610041
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    Guangzhou, 510180
    China

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    China

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    Haikou, 570311
    China

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    Hangzhou, 310003
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    Hangzhou, 310003
    China

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    Lanzhou, 730030
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    Nantong, 226001
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    ShangHai, 200032
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    Shanghai, 200032
    China

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    China

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    Tianjin, 300052
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    Brno, 625 00
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    Czechia

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    Praha 2, 12800
    Czechia

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    Al Mansurah, 35516
    Egypt

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    Alexandria, 21561
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    Alexandria, 21131
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    Cairo, 1181
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    Cairo, 11211
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    Cairo, 12655
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    Cairo, 11976
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    Egypt

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    Amiens, 80054
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    France

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    Brest, 29609
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    Nantes, 44093
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    Poitiers, 86021
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    Berlin, 10707
    Germany

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    Essen, 45147
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    München, 80634
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    Athens, 12462
    Greece

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    Athens, 115 27
    Greece

    Completed

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    Athens, 115 27
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  • Laiko General Hospital of Athens

    Athens, 11527
    Greece

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    Athens 264371, 12462
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    Athens 264371, 11527
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    Larissa, 41110
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    Patras, 26504
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    Pátrai, 26504
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    Thessaloniki, 54636
    Greece

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  • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

    Budapest, 1097
    Hungary

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    Hungary

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    Budapest, 1083
    Hungary

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    Budapest 3054643, 1097
    Hungary

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  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

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    Gyõr, 9023
    Hungary

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    Kaposvar, 7400
    Hungary

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    Kaposvár, 7400
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    Kecskemét, 6000
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    Nyíregyháza, 4400
    Hungary

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  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7622
    Hungary

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  • Ha'Emek Medical Center

    Afula, 1834111
    Israel

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    Beer Sheva, 8410101
    Israel

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  • Soroka Medical Center

    Beersheba, 8410101
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    Haifa, 3109601
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    Jerusalem, 9112001
    Israel

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    Jerusalem, 9112001
    Israel

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  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

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    Jerusalem 281184, 9112001
    Israel

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  • Hospital Sanz Medical Center Laniado Hospital

    Kiryat Tzanz, 4244916
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  • Rabin Medical Center, Beilinson Hospital

    Petach Tikvah, 49100
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    Tel Aviv, 64239
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  • Ospedale Mazzonl

    Ascoli Piceno, 63100
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  • PO C e G Mazzoni AST Ascoli Piceno

    Ascoli Piceno, 63100
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    Brescia, 25123
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  • ASST Spedali Civili di Brescia

    Brescia, 25123
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  • AOU Policlinico G Rodolico S Marco

    Catania, 95125
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  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

    Catania, 95122
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    Catania, 95123
    Italy

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    Catania 2525068, 95125
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  • Careggi University Hospital

    Firenze, 50134
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    Florence, 50134
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    Milan, 20122
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    Milano, 21022
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    Monza, 20900
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    Monza, 20900
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    Novara, 28100
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    Novara, 28100
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    Roma, 00168
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    Torino, 10126
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    Torino, 10126
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    Vicenza, 36100
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    Vicenza, 36100
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    Fukushima, 960 1295
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    Iruma-gun, 350-0495
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    Kanagawa, 216 8511
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    Kanagawa, 216-8511
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    Kitakyusyu-Shi, 806-8501
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    Gdansk, 80-214
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    Katowice, 40 519
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    Lodz, 93 510
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    Burgos, 09006
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    Córdoba, 14004
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    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031
    Spain

    Site Not Available

  • Hosp. Univ. La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hosp. Univ. Infanta Leonor

    Madrid 3117735, 28031
    Spain

    Active - Recruiting

  • Hosp. Univ. La Paz

    Madrid 3117735, 28046
    Spain

    Active - Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid 3117735, 28034
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid 3117735, 28040
    Spain

    Completed

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222
    Spain

    Site Not Available

  • Hosp Regional Univ de Malaga

    Málaga, 29010
    Spain

    Site Not Available

  • Hosp Virgen de La Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hosp. Regional Univ. de Malaga

    Málaga, 29010
    Spain

    Completed

  • Hosp. Virgen Del Rocio

    Málaga, 29010
    Spain

    Site Not Available

  • Hosp. Virgen de La Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hosp Regional Univ de Malaga

    Málaga 2514256, 29010
    Spain

    Completed

  • Hosp Virgen de La Victoria

    Málaga 2514256, 29010
    Spain

    Completed

  • Hosp. Son Llatzer

    Palma de Mallorca, 07198
    Spain

    Site Not Available

  • Clinica Univ. De Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcon, 28223
    Spain

    Active - Recruiting

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Cherkassy Regional Oncology Dispensary, Department of Hematology

    Cherkassy, 18009
    Ukraine

    Site Not Available

  • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

    Dnipro, 49102
    Ukraine

    Site Not Available

  • Kyiv City Clinical Hospital #9, Department of infectious diseases

    Kyiv, 04112
    Ukraine

    Site Not Available

  • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

    Kyiv, 02091
    Ukraine

    Site Not Available

  • Kyiv City Clinical Hospital #9, Department of infectious diseases

    Kyiv 703448, 04112
    Ukraine

    Terminated

  • Mykolaiv Regional Clinical Hospital

    Mykolaiv, 54058
    Ukraine

    Site Not Available

  • Ternopil University Hospital of Ternopil Regional Council

    Ternopil, 46002
    Ukraine

    Site Not Available

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LF9 7TF
    United Kingdom

    Site Not Available

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP
    United Kingdom

    Active - Recruiting

  • Barts Health NHS Trust

    London, E1 2ES
    United Kingdom

    Site Not Available

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO166YD
    United Kingdom

    Site Not Available

  • Palo Verde Cancer Specialists

    Glendale, Arizona 85304
    United States

    Site Not Available

  • MemorialCare Medical Group

    Fountain Valley, California 92708
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Compassionate Cancer Care

    Riverside, California 92501
    United States

    Site Not Available

  • Compassionate Cancer Care Medical Group

    Riverside, California 92501
    United States

    Active - Recruiting

  • American Institute of Research

    Whittier, California 90603
    United States

    Site Not Available

  • University of Colorado - Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Research Network

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • GNP Research

    Cooper City, Florida 33024
    United States

    Site Not Available

  • Heme Onc Call

    Cooper City, Florida 33024
    United States

    Active - Recruiting

  • University of Florida College of Medicine

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of Florida Health Jacksonville

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • University of Florida Health Jacksonville - Rheumatology

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Universal Clinical Research Inc.

    Hialeah, Florida 33012
    United States

    Site Not Available

  • 21st Century Oncology

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Lakes Research

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • AdventHealth Cancer Institute

    Orlando, Florida 32804
    United States

    Site Not Available

  • Children's Research Institute

    Saint Petersburg, Florida 33701
    United States

    Active - Recruiting

  • Children's Research Institute

    St. Petersburg, Florida 33701
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Alliance for Multispeciality Research

    Merriam, Kansas 66204
    United States

    Site Not Available

  • Tulane University School of Medicine

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Henry Ford Medical Center

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Research Medical Center

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203
    United States

    Site Not Available

  • Montefiore Medical Center

    Lake Success, New York 11042
    United States

    Site Not Available

  • Monter Cancer Center

    Lake Success, New York 11042
    United States

    Site Not Available

  • Hematology Oncology Associates of Rockland

    Nyack, New York 10960
    United States

    Site Not Available

  • Monter Cancer Center

    Lake Success 5123853, New York 5128638 11042
    United States

    Completed

  • University of North Carolina Hemophilia and Thrombosis Center

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • East Carolina University-School of Medicine

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Scotland Cancer Treatment Center - Duke Cancer Network

    Laurinburg, North Carolina 28352
    United States

    Active - Recruiting

  • Taussig Cancer Insititute - Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Taussig Cancer Insititute Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Ohio State University- James Cancer Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • INTEGRIS Southwest Medical Center

    Oklahoma City, Oklahoma 73109
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Completed

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • NorthWest Medical Specialties, PLLC

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • Northwest Medical Specialists

    Tacoma, Washington 98405
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

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