Clinical trial NCT01039376: Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy
Official title: A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Leukaemia, Lymphocytic, Chronic
Keywords: maintenance therapy
anti-CD20 monoclonal antibody
ofatumumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-25
Enrollment: 480
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.

Detailed description: The study met its primary objective at the protocol defined interim analysis (data cut-off 19-Jun-2014). The protocol-defined final analysis of the primary endpoint was performed when 280 PFS events were reached (data cut-off 20-Feb-2017).

Eligibility criteria: Inclusion Criteria:

* Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines (Hallek, 2008)
* At least PR according to the revised 2008 NCI-WG CLL criteria, within 3 months of the response assessment after the last dose of 2nd/3rd line treatment
* The anti-leukemic treatment before study entry should have been at least 3 months or 3 cycles
* ECOG Performance Status of 0-2
* Signed written informed consent prior to performing any study-specific procedures

Exclusion Criteria:

* Known primary or secondary fludarabine-refractory subjects, defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months
* Prior maintenance therapy
* Known transformation of CLL (eg.Richter's transformation), prolymphocytic leukemia (PLL), or CNS involvement of CLL
* Active Autoimmune hemolytic anemia (AIHA) requiring treatment except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data
* Previous autologous or allogeneic stem cell transplantation
* Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis B or C
* Other past or current malignancy (with the exception of basal cell carcinoma or the skin or in situ carcinoma of the cervix or breasts) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data
* Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of exta systoles or minor conduction abnormalities except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data
* History of significant cerebrovascular disease or event with symptoms or sequelae
* Significant concurrent, uncontrolled medical condition that in the opinion of the investigator or GSK medical monitor contraindicates participation in this study
* Other anti-leukemic use of medications including glucocorticoids
* Known HIV positive
* Screening laboratory values: platelets \<50 x 10x9/L, neutrophils\<1.0 x 10x9/L, Creatinine \> 1.5 X upper normal limit (unless normal creatinine clearance), total bilirubin \>1.5 X upper normal limit, ALT \>2.5 X upper normal limit (unless due to liver involvement of CLL), alkaline phosphase \> 2.5 X upper normal limit
* Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor contraindicates study participation
* Subjects who have received treatment with any non-marketed drug substance or experimental therapy within 5-terminal half-lives or 4 weeks whichever is longer prior to first dose of study medication or currently participating in any other interventional clinical study
* Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last ofatumumab dose. Adequate contraception is defined as abstinence, oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is sole partner for that subject. For females in the USA, the use of a double barrier method is also considered adequate (condom or occlusive cap plus spermicidal agent).

Primary outcomes:
measure: Progression-free Survival, as Assessed by the Investigator
timeFrame: From randomization until progression or death (up to 79 months)
measure: Progression-free Survival, as Assessed by the Independent Review Committee (IRC)
timeFrame: From randomization until progression or death (up to 79 months)
Secondary outcomes:
measure: Overall Survival
timeFrame: From randomization until death (up to 88 months)
measure: Number of Participants With Improvement in Response From Baseline
timeFrame: From Baseline until the end of the study (up to 88 months)
measure: Time to Next Therapy
timeFrame: From randomization until the end of the study (up to 88 months)
measure: Progression-free Survival After Next-line Therapy
timeFrame: From randomization until progression or death (up to 88 months)
measure: Time to Progression After Next-line Therapy
timeFrame: From randomization until progression or death (up to 88 months)
measure: Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
timeFrame: From randomization until the end of the study (up to 47 months)
measure: Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
timeFrame: From randomization until the end of the study (up to 47 months)
measure: Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale
timeFrame: From screening until the end of the study (up to 47 months)
measure: Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points
timeFrame: From randomization until the end of the study (up to 88 months)
measure: Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points
timeFrame: From Screening until the end of the study (up to 88 months)
measure: Number of Participants With Grade 3 and Above Adverse Event of Infection
timeFrame: From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 26 months)
measure: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
timeFrame: From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until end of study for SAEs (88 months)
measure: Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points
timeFrame: From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until the end of the study for SAEs (88 months)
measure: Number of Participants Who Received at Least One Transfusion During the Study
timeFrame: From randomization until the end of the study (up to 88 months)
measure: Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)
timeFrame: From randomization until the end of the study (up to 88 months)
measure: Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result
timeFrame: Pre-dose (Visit 1), Months 7, 13, 19, and 25 during treatment and at 3 and 6 months after last ofatumumab dose (up to 30 months)
measure: Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points
timeFrame: Baseline, every six months during treatment, and after last treatment visit and/or upon relapse (up to 88 months)
measure: Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit
timeFrame: From randomization until the end of the study (up to 88 months)
measure: Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points
timeFrame: Baseline and every two months from Month 3 until Month 25 and at every followup (up to 88 months)
measure: Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers
timeFrame: From Baseline until the end of the study (up to 79 months)
measure: Cmax and Ctrough of Ofatumumab
timeFrame: Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
measure: Total Plasma Clearance (CL) of Ofatumumab
timeFrame: Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
measure: AUC(0-tau) of Ofatumumab
timeFrame: Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
measure: Vss of Ofatumumab
timeFrame: Day 1 Month 1 ( Cycle 1) through Month 7 ( Cycle 4)
measure: Plasma Half-life (t1/2) of Ofatumumab
timeFrame: Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Jonesboro
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Berkeley
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facility: Novartis Investigative Site
state: California
city: La Verne
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facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: San Pablo
country: United States
facility: Novartis Investigative Site
state: California
city: Hartford
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Lake Worth
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facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pembroke Pines
country: United States
facility: Novartis Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Macon
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Savannah
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Post Falls
country: United States
facility: Novartis Investigative Site
state: Idaho
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Iowa City
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Westwood
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Metairie
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Cumberland
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Hagerstown
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Worcester
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Detroit
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facility: Novartis Investigative Site
state: Michigan
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Henderson
country: United States
facility: Novartis Investigative Site
state: Nevada
city: New Brunswick
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Novartis Investigative Site
state: New Mexico
city: Albuquerque
country: United States
facility: Novartis Investigative Site
state: New Mexico
city: Mineola
country: United States
facility: Novartis Investigative Site
state: New York
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Chapel Hill
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Greenville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Chattanooga
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Orem
country: United States
facility: Novartis Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Capital Federal
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Derqui, Pilar
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Darlinghurst
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Randwick
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: East Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Brussels
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Hasselt
country: Belgium
facility: Novartis Investigative Site
city: Roeselare
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Salvador
country: Brazil
facility: Novartis Investigative Site
state: Bahía
city: Goiania - GO
country: Brazil
facility: Novartis Investigative Site
state: Goiás
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Novartis Investigative Site
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: São Paulo
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Kitchener
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
city: Olomouc
country: Czechia
facility: Novartis Investigative Site
city: Pelhrimov
country: Czechia
facility: Novartis Investigative Site
city: Praha 10
country: Czechia
facility: Novartis Investigative Site
city: Herlev
country: Denmark
facility: Novartis Investigative Site
city: Kobenhavn
country: Denmark
facility: Novartis Investigative Site
city: Roskilde
country: Denmark
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: Jyvaskyla
country: Finland
facility: Novartis Investigative Site
city: Pori
country: Finland
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Blois cedex
country: France
facility: Novartis Investigative Site
city: Caen cedex 5
country: France
facility: Novartis Investigative Site
city: Clermont-Ferrand Cedex 1
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Lille cedex
country: France
facility: Novartis Investigative Site
city: Marseille Cedex 9
country: France
facility: Novartis Investigative Site
city: Mulhouse
country: France
facility: Novartis Investigative Site
city: Pessac cedex
country: France
facility: Novartis Investigative Site
city: Saint Pierre cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg cedex
country: France
facility: Novartis Investigative Site
city: Toulouse cedex 9
country: France
facility: Novartis Investigative Site
city: Vandoeuvre-Les-Nancy
country: France
facility: Novartis Investigative Site
city: Athens,
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Piraeus
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Kecskemet
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Ahmedabad
country: India
facility: Novartis Investigative Site
city: Mumbai
country: India
facility: Novartis Investigative Site
city: Mumbai
country: India
facility: Novartis Investigative Site
city: Pune
country: India
facility: Novartis Investigative Site
city: Afula
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Kfar Saba
country: Israel
facility: Novartis Investigative Site
city: Nahariya
country: Israel
facility: Novartis Investigative Site
city: Petach-Tikva
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Tel-Aviv
country: Israel
facility: Novartis Investigative Site
city: Zrifin
country: Israel
facility: Novartis Investigative Site
city: Modena
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Piacenza
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Novara
country: Italy
facility: Novartis Investigative Site
state: Piemonte
city: Torino
country: Italy
facility: Novartis Investigative Site
state: Piemonte
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: Toscana
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Amersfoort
country: Netherlands
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Blaricum
country: Netherlands
facility: Novartis Investigative Site
city: Breda
country: Netherlands
facility: Novartis Investigative Site
city: Den Bosch
country: Netherlands
facility: Novartis Investigative Site
city: Den Haag
country: Netherlands
facility: Novartis Investigative Site
city: Deventer
country: Netherlands
facility: Novartis Investigative Site
city: Dordrecht
country: Netherlands
facility: Novartis Investigative Site
city: Enschede
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Hoofddorp
country: Netherlands
facility: Novartis Investigative Site
city: Leiden
country: Netherlands
facility: Novartis Investigative Site
city: Maastricht
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Sittard-geleen
country: Netherlands
facility: Novartis Investigative Site
city: Tilburg
country: Netherlands
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Chorzow
country: Poland
facility: Novartis Investigative Site
city: Slupsk
country: Poland
facility: Novartis Investigative Site
city: Szczecin
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: San Juan
country: Puerto Rico
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Penza
country: Russian Federation
facility: Novartis Investigative Site
city: St'Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St'Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Volgograd
country: Russian Federation
facility: Novartis Investigative Site
city: Hospitalet de Llobregat (Barcelona)
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Salamanca
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Toledo
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Goteborg
country: Sweden
facility: Novartis Investigative Site
city: Linkoping
country: Sweden
facility: Novartis Investigative Site
city: Lulea
country: Sweden
facility: Novartis Investigative Site
city: Orebro
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Cherkasy
country: Ukraine
facility: Novartis Investigative Site
city: Dnipropetrovsk
country: Ukraine
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Khmelnytskyi
country: Ukraine
facility: Novartis Investigative Site
city: Kyiv
country: Ukraine
facility: Novartis Investigative Site
city: Lviv
country: Ukraine
facility: Novartis Investigative Site
city: Makiivka
country: Ukraine
facility: Novartis Investigative Site
city: Vinnitsa
country: Ukraine
facility: Novartis Investigative Site
city: Zhytomyr
country: Ukraine
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: