Clinical trial NCT04384484: Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Official title: A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Relapsed Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Keywords: Loncastuximab Tesirine
Refractory Diffuse Large B-Cell Lymphoma
Relapsed Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Lymphoma
Lead sponsor: ADC Therapeutics S.A.
Sponsor class: INDUSTRY
First posted: 2020-05-12
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy.


Eligibility criteria: Inclusion Criteria:

* Male or female participant aged 18 years or older
* Pathologic diagnosis of DLBCL, as defined by the 2016 World Health Organization classification (including participants with DLBCL transformed from indolent lymphoma), or high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
* Relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) disease following at least one multi-agent systemic treatment regimen \[For China only: Adequate first line anti-DLBCL therapy is defined as having received at least 4 cycles of multiagent systemic treatment regimen containing rituximab and anthracycline, unless the participants are intolerant to the regimen, or had disease progression during the treatment. If disease progression occurred during the treatment period, then the disease is considered refractory where the number of treatment cycles will not be specified. For participants who are ineligible for anthracycline, anthracycline is not required.\]
* Not considered by the investigator to be a candidate for stem cell transplantation based on performance status, advanced age, and/or significant medical comorbidities such as organ dysfunction
* Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if tumor is not fluorodeoxyglucose (FDG)-avid on screening PET-CT
* Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available) Note: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred \[For China only: This inclusion criterion is not applicable\]
* ECOG performance status 0-2
* Adequate organ function as defined by screening laboratory values within the following parameters:

  1. Absolute neutrophil count ≥1000/μL (off growth factors for at least 72 hours)
  2. Platelet count ≥100000/μL without transfusion within the past 2 weeks
  3. ALT, AST, and GGT ≤2.5 × the upper limit of normal (ULN)
  4. Total bilirubin ≤1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN)
  5. Calculated creatinine clearance ≥30 mL/min by the Cockcroft and Gault equation

Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility.

* Negative beta-human chorionic gonadotropin (β-hCG) pregnancy test within 7 days prior to start of study drug (Cycle 1 Day 1) for women of childbearing potential
* Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 12 months after the last dose of study treatment. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent until at least 7 months after the participant receives his last dose of study treatment.

Exclusion Criteria:

* Previous treatment with loncastuximab tesirine
* Previous treatment with R-GemOx
* Known history of hypersensitivity to a CD19 antibody, loncastumiximab tesirine (including SG3249) or any of its excipients, or history of positive serum human ADA to a CD19 antibody
* Pathologic diagnosis of Burkitt lymphoma
* Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary
* Autologous transplant within 30 days prior to start of study drug (Cycle 1 Day 1)
* Allogeneic transplant within 60 days prior to start of study drug (Cycle 1 Day 1)
* Active graft-versus-host disease
* Post-transplantation lymphoproliferative disorders
* Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease
* Human immunodeficiency virus (HIV) seropositive with any of the following:

  1. CD4+ T-cell (CD4+) counts \<350 cells/μL
  2. Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening
  3. Not on anti-retroviral therapy, or on anti-retroviral therapy for \<4 weeks at the time of screening
  4. HIV viral load ≥400 copies/mL
* Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
* Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
* History of Stevens-Johnson syndrome or toxic epidermal necrolysis
* Lymphoma with active CNS involvement, including leptomeningeal disease
* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
* Breastfeeding or pregnant
* Uncontrolled hypertension (blood pressure ≥160/100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the participant's ability to tolerate the study treatment
* Major surgery within 4 weeks prior to start of study drug (Cycle 1 Day 1); radiotherapy, chemotherapy or other antineoplastic therapy within 14 days prior to start of study drug (Cycle 1 Day 1), except shorter if approved by the Sponsor
* Use of any other experimental medication within 14 days or 5 half-lives prior to start of study drug (Cycle 1 Day 1)
* Received live vaccine within 4 weeks of Cycle 1 Day 1
* Failure to recover to ≤Grade 1 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) from acute non-hematologic toxicity (except alopecia) due to previous therapy prior to screening
* Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)
* Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participant inappropriate for study participation or put the participant at risk
* Known history of hypersensitivity to oxaliplatin or other platinum-based drugs, or gemcitabine, or rituximab, or any of their excipients

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 4 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 4 years
measure: Overall Response Rate (ORR)
timeFrame: Up to 4 years
measure: Complete Response Rate (CRR)
timeFrame: Up to 4 years
measure: Duration of Response (DOR)
timeFrame: Up to 4 years
measure: Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Day 1 up to a maximum of Week 39
measure: Number of Participants Who Experience At Least One Serious Adverse Event (SAE)
timeFrame: Up to 4 years
measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results
timeFrame: Day 1 up to a maximum of Week 25
measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements
timeFrame: Day 1 up to a maximum of Week 25
measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Physical Examinations
timeFrame: Day 1 up to a maximum of Week 25
measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Day 1 up to a maximum of Week 25
measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECG) Results
timeFrame: Day 1 up to a maximum of Week 25
measure: Average Concentration of Loncastuximab Tesirine at the End of Infusion
timeFrame: Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)
measure: Average Concentration of Loncastuximab Tesirine Before Infusion
timeFrame: Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)
measure: Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
timeFrame: Day 1 up to a maximum of Week 25
measure: Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Core 30 (EORTC QLQ-C30)
timeFrame: Baseline up to a maximum of Week 25
measure: Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by the Lymphoma Subscale of Functional Assessment of Cancer Therapy- Lymphoma (LymS of FACT-Lym)
timeFrame: Baseline up to a maximum of Week 25
measure: Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by GP5 Item of the Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)
timeFrame: Baseline up to a maximum of Week 25
measure: Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
timeFrame: Baseline to up to 4 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: Redlands
country: United States
facility: Redlands Community Hospital
state: California
city: Whittier
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Des Moines
country: United States
facility: UnityPoint Health - Iowa Oncology Research Association (IORA)
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Henderson
state: Nevada
city: Portland
country: United States
facility: Kaiser Permanente Interstate Medical Office Central
state: Oregon
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Gainesville
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center Clinical Trials Office
state: Wisconsin
city: Belgrano
country: Argentina
facility: Clinica Adventista Belgrano
state: Buenos Aires
city: Santa Fe
country: Argentina
facility: Clínica de Nefrología, Urología y Enfermedades Cardiovasculares S.A.
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto Médico Especializado Alexander Fleming
state: Distrito Federal
city: Rosario
country: Argentina
facility: Grupo Gamma - Hospital Privado Rosario
state: Santa Fe
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Namur
country: Belgium
facility: Centre Hospitalier Universitaire Universite Catholique de Louvain
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta - Campus Rumbeke
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus - Centro Integrado de Oncologia
state: Rio Grande Do Sul
city: Rio De Janeiro
country: Brazil
facility: Hospital do Câncer
city: São Paulo
country: Brazil
facility: Hemomed Instituto de Oncologia e Hematologia
city: São Paulo
country: Brazil
facility: A Beneficência Portuguesa de São Paulo - Unidade Mirante
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
city: Edmonton
country: Canada
facility: Cross Cancer Institute
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
city: Sherbrooke
country: Canada
facility: Hôpital Fleurimont
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Instituto Oncológico Fundación Arturo López Pérez
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: CeCim - Centro de Estudios Clínicos e Investigaciones Médicas
state: Región Metropolitana De Santiago
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital - Zhengzhou University
state: Henan
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: West China School of Medicine - West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital - Chongqing Cancer Hospital
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital of CAMS - PUMC
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Wuhan
country: China
facility: Tongji Hospital
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Prague
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady
city: Prague
country: Czechia
facility: Fakultni nemocnice v Motole
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire Brest
state: Bretagne
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire Brest
city: Dijon
country: France
facility: Hôpital François Mitterrand
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Paris
country: France
facility: Hopital Universitaire Pitie Salpetriere
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
city: Rouen
country: France
facility: Centre de Lutte Contre le Cancer - Centre Henri-Becquerel
city: Heves
country: Hungary
facility: Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet
state: Budapest
city: Budapest
country: Hungary
facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László
state: Pest
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Ashdod
country: Israel
facility: Samson Assuta Ashdod University Hospital
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
city: Tel Aviv
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Udine
country: Italy
facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia
state: Friuli Venezia Giulia
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
city: Florence
country: Italy
facility: Azienda Ospedaliero - Universitaria Careggi
city: Foggia
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milan
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
city: Milan
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Ravenna
country: Italy
facility: Sanitaria Locale della Romagna
city: Nagoya
country: Japan
facility: National Hospital Organization - Nagoya Medical Center
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama
country: Japan
facility: Matsuyama Red Cross Hospital
state: Ehime
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Sapporo
country: Japan
facility: Sapporo Hokuyu Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Cancer Center
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Nagasaki-city
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Hidaka-Shi
country: Japan
facility: Saitama Medical University - International Medical Center
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
state: Tokyo
city: Tachikawa
country: Japan
facility: National Hospital Organization Disaster Medical Center
state: Tokyo
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Gifu
country: Japan
facility: Gifu Municipal Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Osaka
country: Japan
facility: Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
city: Guadalajara
country: Mexico
facility: Boca Raton Clinical Research (BRCR) Global Mexico - Guadalajara
state: Jalisco
city: Guadalajara
country: Mexico
facility: PanAmerican Clinical Research Mexico - Guadalajara
state: Jalisco
city: Cuernavaca
country: Mexico
facility: PanAmerican Clinical Research Mexico - Cuernavaca
state: Morelos
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González
state: Nuevo Leon
city: Huixquilucan
country: Mexico
facility: Hematológica Alta Especialidad
city: Mexico City
country: Mexico
facility: Boca Raton Clinical Research (BRCR) Global Mexico - Ciudad de México
city: Den Haag
country: Netherlands
facility: Hagaziekenhuis Van Den Haag - Leyweg
state: South Holland
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis - Elisabeth
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
state: Dolnoslaskie
city: Kraków
country: Poland
facility: Pratia MCM Kraków
state: Malopolskie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Opole
country: Poland
facility: Szpital Wojewódzki w Opolu
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznań
city: Warszawa
country: Poland
facility: Instytut Hematologii I Transfuzjologii
city: Łódź
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
city: San Juan
country: Puerto Rico
facility: Hospital Español Auxilio Mutuo
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut Mar
city: Barcelona
country: Spain
facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana
city: Çukurambar
country: Turkey
facility: Özel Koru Hastanesi
state: Ankara
city: Şişli
country: Turkey
facility: VKV Amerikan Hastanesi
state: Istanbul
city: Bornova
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
state: Izmir
city: Kurupelit
country: Turkey
facility: Ondokuz Mayis Üniversitesi
state: Samsun
city: Ortahisar
country: Turkey
facility: Karadeniz Teknik Üniversitesi Tip Fakültesi
state: Trabzon
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi - Cebeci Arastirma ve Uygulama Hastanesi
city: Kayseri
country: Turkey
facility: Mehmet Kemal Dedeman Hematoloji Hastanesi
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: England
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References: