Clinical trial NCT01724346: Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official title: An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Keywords: CLL
SLL
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2012-11-09
Enrollment: 269
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)


Eligibility criteria: Inclusion Criteria:

1. Randomized in the parent study, PCYC-1115-CA
2. Informed consent for Study PCYC-1116-CA
3. Independent review committee (IRC)-confirmed disease progression (PD) in the parent study PCYC-1115-CA or closure of the parent study

Exclusion Criteria:

1. Disease progression involving the central nervous system (CNS) or transformation to another histology
2. Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease
3. In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug
4. Requirement for treatment with a strong CYP3A inhibitor
5. Uncontrolled systemic infection or requirement for IV antibiotics
6. Noncompliance on the parent study(PCYC-1115-CA)

Primary outcomes:
measure: Progression Free Survival (PFS) Based on Investigator Assessment
timeFrame: Median overall follow-up of 82.7 months
Secondary outcomes:
measure: Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2)
timeFrame: Median overall follow-up of 82.7 months
measure: Overall Survival (OS)
timeFrame: Median overall follow-up of 82.7 months
measure: Time to Next Treatment (TTNT)
timeFrame: Median overall follow-up of 82.7 months
measure: Overall Response Rate (ORR)
timeFrame: Median overall follow-up of 82.7 months
measure: Rate of Minimal Residual Disease (MRD) Negativity
timeFrame: Median overall follow-up of 82.7 months
measure: Duration of Response (DOR)
timeFrame: Median overall follow-up of 82.7 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope /ID# 1116-0047
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center at UC San Diego /ID# 1116-0408
state: California
city: Stanford
country: United States
facility: Stanford University/Stanford Cancer Center, Campus Drive /ID# 1116-0038
state: California
city: Chicago
country: United States
facility: University of Chicago /ID# 1116-0126
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute - St Matthews /ID# 1116-0071
state: Kentucky
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada /ID# 1116-0712
state: Louisiana
city: Worcester
country: United States
facility: University of Massachusetts - Worcester /ID# 1116-0307
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 1116-0221
state: Missouri
city: New Hyde Park
country: United States
facility: Northwell Health/Long Island Jewish Hospital /ID# 1116-0350
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center /ID# 1116-0127
state: New York
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center /ID# 1116-0656
state: North Carolina
city: Portland
country: United States
facility: Kaiser Permanente - Northwest /ID# 1116-0677
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1116-0050
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center /ID# 1116-0032
state: Texas
city: San Antonio
country: United States
facility: Oncology of San Antonio /ID# 1116-0653
state: Texas
city: Walla Walla
country: United States
facility: Providence St. Mary Regional Cancer Center /ID# 1116-0731
state: Washington
city: Kogarah
country: Australia
facility: St George Hospital /ID# 1116-0654
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital /ID# 1116-0503
state: Queensland
city: Bedford, Park
country: Australia
facility: Flinders Medical Centre /ID# 1116-0163
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart /ID# 1116-0555
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital /ID# 1116-0193
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre /ID# 1116-0556
state: Victoria
city: Fitzroy Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne /ID# 1116-0501
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health /ID# 1116-0170
state: Victoria
city: Antwerp
country: Belgium
facility: ZNA Cadix /ID# 1116-0561
state: Antwerpen
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 1116-0164
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 1116-0560
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 1116-0559
state: Vlaams-Brabant
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre /ID# 1116-0157
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute /ID# 1116-0018
state: Alberta
city: Beijing
country: China
facility: Beijing Cancer Hospital /ID# 1116-0670
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 1116-0673
state: Beijing
city: Nanjing
country: China
facility: Jiangsu Province Hospital /ID# 1116-0671
state: Jiangsu
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 1116-0675
state: Zhejiang
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno /ID# 1116-0562
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove /ID# 1116-0564
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen /ID# 1116-0566
city: Dublin 8
country: Ireland
facility: St James Hospital /ID# 1116-0570
state: Dublin
city: Galway
country: Ireland
facility: University Hospital Galway /ID# 1116-0571
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 1116-0576
state: H_efa
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 1116-0573
state: H_efa
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 1116-0575
state: H_efa
city: Nahariya
country: Israel
facility: Galilee Medical Center /ID# 1116-0578
state: HaTsafon
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 1116-0577
state: Yerushalayim
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 1116-0856
city: Bologna
country: Italy
facility: Institute of Hematology Seràgnoli /ID# 1116-0580
state: Emilia-Romagna
city: Milan
country: Italy
facility: Ospedale San Raffaele IRCCS /ID# 1116-0523
state: Milano
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 1116-0581
state: Milano
city: Rome
country: Italy
facility: Università La Sapienza /ID# 1116-0583
state: Roma
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 1116-0584
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena /ID# 1116-0524
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 1116-0582
city: Padova
country: Italy
facility: Universita degli Studi di Padova /ID# 1116-0527
city: Rome
country: Italy
facility: Policlinico Universitario A Gemelli /ID# 1116-0891
city: Grafton
country: New Zealand
facility: Auckland City Hospital /ID# 1116-0588
state: Auckland
city: Takapuna
country: New Zealand
facility: North Shore Hospital /ID# 1116-0663
state: Auckland
city: Hamilton
country: New Zealand
facility: Haematology Waikato Hospital /ID# 1116-0586
state: Waikato
city: Wellington South
country: New Zealand
facility: Wellington Blood and Cancer Centre /ID# 1116-0587
state: Wellington
city: Christchurch
country: New Zealand
facility: Canterbury Health Labs Canterbury Disrict Health Board /ID# 1116-0589
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o. /ID# 1116-0363
state: Mazowieckie
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. /ID# 1116-0592
state: Podkarpackie
city: Gdańsk
country: Poland
facility: Samodzielny Publiczny Szpital Klinczny Nr-1- Akademickie Cenrum Klinic /ID# 1116-0529
state: Pomorskie
city: Chorzow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 1116-0591
state: Slaskie
city: Lodz
country: Poland
facility: Medical Univ. of Lodz and Copernicus Memorial Hospital /ID# 1116-0531
city: Ryazan
country: Russian Federation
facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 1116-0707
state: Ryazanskaya Oblast
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals /ID# 1116-0604
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda /ID# 1116-0536
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 1116-0534
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 1116-0533
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 1116-0535
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 1116-0537
city: Yenimahalle
country: Turkey
facility: Gazi Universitesi Tip Fakultes /ID# 1116-0608
state: Ankara
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Ibn-i Sina /ID# 1116-0606
city: Izmir
country: Turkey
facility: Ic Hastaliklari Anabilim Dali/Ege University Medical Faculty /ID# 1116-0714
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty /ID# 1116-0601
city: Kayseri
country: Turkey
facility: Erciyes Universiitesi Tip Fakultesi /ID# 1116-0602
city: Vinnytsia
country: Ukraine
facility: CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 1116-0595
state: Vinnytska Oblast
city: Cherkasy
country: Ukraine
facility: Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 1116-0597
city: Dnipro
country: Ukraine
facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 1116-0594
city: Lviv
country: Ukraine
facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 1116-0596
city: Poole
country: United Kingdom
facility: University Hospitals Dorset NHS Foundation Trust /ID# 1116-0551
state: Dorset
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust /ID# 1116-0367
state: Hampshire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust /ID# 1116-0548
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 1116-0668
state: Oxfordshire
city: Cardiff
country: United Kingdom
facility: Cardiff & Vale University Health Board /ID# 1116-0607
state: Wales
city: Colchester
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust /ID# 1116-0549
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 1116-0550
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust /ID# 1116-0544
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Barr PM, Owen C, Robak T, Tedeschi A, Bairey O, Burger JA, Hillmen P, Coutre SE, Dearden C, Grosicki S, McCarthy H, Li JY, Offner F, Moreno C, Zhou C, Hsu E, Szoke A, Kipps TJ, Ghia P. Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Adv. 2022 Jun 14;6(11):3440-3450. doi: 10.1182/bloodadvances.2021006434.
citation: Coutre SE, Byrd JC, Hillmen P, Barrientos JC, Barr PM, Devereux S, Robak T, Kipps TJ, Schuh A, Moreno C, Furman RR, Burger JA, O'Dwyer M, Ghia P, Valentino R, Chang S, Dean JP, James DF, O'Brien SM. Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies. Blood Adv. 2019 Jun 25;3(12):1799-1807. doi: 10.1182/bloodadvances.2018028761.
citation: Barr PM, Robak T, Owen C, Tedeschi A, Bairey O, Bartlett NL, Burger JA, Hillmen P, Coutre S, Devereux S, Grosicki S, McCarthy H, Li J, Simpson D, Offner F, Moreno C, Zhou C, Styles L, James D, Kipps TJ, Ghia P. Sustained efficacy and detailed clinical follow-up of first-line ibrutinib treatment in older patients with chronic lymphocytic leukemia: extended phase 3 results from RESONATE-2. Haematologica. 2018 Sep;103(9):1502-1510. doi: 10.3324/haematol.2018.192328. Epub 2018 Jun 7.