Spots Global Cancer Trial Database for A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
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Trial Identification
Brief Title: A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
Official Title: Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL) (VENICE II)
Study ID: NCT02980731
Conditions
Interventions
Study Description
Brief Summary: The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on the quality of life of participants including those with with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow) with or without the 17p deletion or TP53 mutation, including participants with an unknown status, as well as R/R CLL participants who had been previously treated with B-cell receptor inhibitor (BCRi) therapy. The starting dose of venetoclax was 20 mg once daily. The dose must have been gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants may have continued receiving venetoclax for up to 2 years. After the treatment period, participants may have continued on into a 2-year follow-up period.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Italiano La Plata /ID# 150812, La Plata, Buenos Aires, Argentina
Fundaleu /Id# 150811, Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Cemic /Id# 150810, Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Sanatorio Allende /ID# 150813, Cordoba, , Argentina
St George Hospital /ID# 154212, Kogarah, New South Wales, Australia
Liverpool Hospital /ID# 154950, Liverpool, New South Wales, Australia
Gold coast University Hospital /ID# 150833, SouthPort, Queensland, Australia
Peter MacCallum Cancer Ctr /ID# 154948, Melbourne, Victoria, Australia
Perth Blood Institute Ltd /ID# 154949, Nedlands, Western Australia, Australia
UMHAT Alexandrovska EAD /ID# 162987, Sofiya, Sofia, Bulgaria
UMHAT Sveti Georgi /ID# 161594, Plovdiv, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 163280, Sofia, , Bulgaria
SHAT Hematologic Diseases /ID# 161592, Sofia, , Bulgaria
Prince of Wales Hospital /ID# 150837, Hong Kong, , Hong Kong
Queen Mary Hospital /ID# 150836, Hong Kong, , Hong Kong
Semmelweis Egyetem /ID# 150792, Budapest, , Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152842, Budapest, , Hungary
Centro de Investigacion Clínica Chapultepec SA de CV /ID# 163641, Morelia, Michoacan, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 150821, Monterrey, Nuevo Leon, Mexico
Middlemore Clinical Trials /ID# 161526, Papatoetoe, Auckland, New Zealand
North Shore Hospital /ID# 157626, Takapuna, Auckland, New Zealand
Wellington Regional Hospital /ID# 157627, Newtown, Wellington, New Zealand
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 150880, Lodz, Lodzkie, Poland
Instytut Hematologii i Transfuzjologii /ID# 150878, Warszawa, Mazowieckie, Poland
Szpitale Pomorskie Sp. z o.o /ID# 164097, Gdynia, Pomorskie, Poland
SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 150877, Chorzow, Slaskie, Poland
Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 166610, Moscow, Moskva, Russian Federation
Moscow State budget healthcare /ID# 154806, Moscow, Moskva, Russian Federation
Regional Oncological Dispensary /ID# 154202, Penza, Penzenskaya Oblast, Russian Federation
Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 154213, Moscow, , Russian Federation
China Medical University Hospital /ID# 150839, Taichung City, , Taiwan
National Taiwan University Hospital /ID# 150838, Taipei City, , Taiwan
Taipei Veterans General Hosp /ID# 153803, Taipei City, , Taiwan
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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