Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Conditions
- Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
- Interventions
- Registration Number
- NCT01724346
- Lead Sponsor
- Pharmacyclics LLC.
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
- Randomized in the parent study, PCYC-1115-CA
- Informed consent for Study PCYC-1116-CA
- IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study
- Disease progression involving the central nervous system (CNS) or transformation to another histology
- Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease
- In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug
- Requirement for treatment with a strong CYP3A inhibitor
- Uncontrolled systemic infection or requirement for IV antibiotics
- Noncompliance on the parent study(PCYC-1115-CA)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Chlorambucil Ibrutinib Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after disease progression (PD). Ibrutinib Next-line ibrutinib Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Based on Investigator Assessment Median overall follow-up of 82.7 months PFS is defined as the time from the date of randomization to the date of disease progression determined by the investigator or date of death from any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to disease progression (PD) or death. Estimated by Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2) Median overall follow-up of 82.7 months PFS2 is defined as the time from the date of randomization to the earliest occurrence of the following three types of events:
* PD per investigator response assessment after initiation of the first subsequent anti-cancer therapy
* Initiation of second subsequent anti-cancer therapy
* Death due to any cause, regardless of administration of subsequent anticancer therapy.
Kaplan-Meier landmark estimate of the PFS2 rate at 60 months (that is, the estimated percentage of participants with PFS2 at Month 60) is presented.Overall Survival (OS) Median overall follow-up of 82.7 months OS is defined as the time from randomization to death due to any cause. Kaplan-Meier landmark estimate of the OS rate at 60 months (that is, the estimated percentage of participants with OS at Month 60) is presented.
Time to Next Treatment (TTNT) Median overall follow-up of 82.7 months Time from randomization to initiation of any subsequent treatment for chronic lymphocytic leukemia (CLL).
Overall Response Rate (ORR) Median overall follow-up of 82.7 months ORR is defined as the percentage of participants who achieve complete response (CR), complete response with an incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR), as determined by the investigator at or prior to initiation of subsequent antineoplastic therapy according to the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.
Rate of Minimal Residual Disease (MRD) Negativity Median overall follow-up of 82.7 months Percentage of participants who achieved MRD-negative response defined as \< 1 CLL cell per 10,000 leukocytes as assessed by flow cytometry of a bone marrow aspirate and/or peripheral blood sample per central laboratory at or prior to initiation of subsequent antineoplastic therapy.
Duration of Response (DOR) Median overall follow-up of 82.7 months DOR will be calculated for the participants achieving a protocol-defined response (Halleck 2008; CR, CRi, nPR, PR) per investigator assessment and is defined as time from the date of initial response including PR with lymphocytosis to the date of disease progression or the date of death from any cause, whichever occurs first.
Trial Locations
- Locations (88)
Hospital Universitario HM Sanchinarro /ID# 1116-0537
🇪🇸Madrid, Spain
Hospital Santa Creu i Sant Pau /ID# 1116-0535
🇪🇸Barcelona, Spain
Gazi Universitesi Tip Fakultes /ID# 1116-0608
🇹🇷Yenimahalle, Ankara, Turkey
Ankara Universitesi Tip Fakultesi Ibn-i Sina /ID# 1116-0606
🇹🇷Ankara, Turkey
City of Hope /ID# 1116-0047
🇺🇸Duarte, California, United States
Moores Cancer Center at UC San Diego /ID# 1116-0408
🇺🇸La Jolla, California, United States
Stanford University/Stanford Cancer Center, Campus Drive /ID# 1116-0038
🇺🇸Stanford, California, United States
University of Chicago /ID# 1116-0126
🇺🇸Chicago, Illinois, United States
Norton Cancer Institute - St Matthews /ID# 1116-0071
🇺🇸Louisville, Kentucky, United States
Comprehensive Cancer Centers of Nevada /ID# 1116-0712
🇺🇸Henderson, Louisiana, United States
University of Massachusetts - Worcester /ID# 1116-0307
🇺🇸Worcester, Massachusetts, United States
Washington University-School of Medicine /ID# 1116-0221
🇺🇸Saint Louis, Missouri, United States
Northwell Health/Long Island Jewish Hospital /ID# 1116-0350
🇺🇸New Hyde Park, New York, United States
University of Rochester Medical Center /ID# 1116-0127
🇺🇸Rochester, New York, United States
Southeastern Medical Oncology Center /ID# 1116-0656
🇺🇸Goldsboro, North Carolina, United States
Kaiser Permanente - Northwest /ID# 1116-0677
🇺🇸Portland, Oregon, United States
University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1116-0050
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson Cancer Center /ID# 1116-0032
🇺🇸Houston, Texas, United States
Oncology of San Antonio /ID# 1116-0653
🇺🇸San Antonio, Texas, United States
Providence St. Mary Regional Cancer Center /ID# 1116-0731
🇺🇸Walla Walla, Washington, United States
St George Hospital /ID# 1116-0654
🇦🇺Kogarah, New South Wales, Australia
Princess Alexandra Hospital /ID# 1116-0503
🇦🇺Woolloongabba, Queensland, Australia
Flinders Medical Centre /ID# 1116-0163
🇦🇺Bedford, Park, South Australia, Australia
Royal Hobart /ID# 1116-0555
🇦🇺Hobart, Tasmania, Australia
Box Hill Hospital /ID# 1116-0193
🇦🇺Box Hill, Victoria, Australia
Monash Medical Centre /ID# 1116-0556
🇦🇺Clayton, Victoria, Australia
St Vincent's Hospital Melbourne /ID# 1116-0501
🇦🇺Fitzroy Melbourne, Victoria, Australia
Austin Health /ID# 1116-0170
🇦🇺Heidelberg, Victoria, Australia
ZNA Cadix /ID# 1116-0561
🇧🇪Antwerp, Antwerpen, Belgium
UCL Saint-Luc /ID# 1116-0164
🇧🇪Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
UZ Gent /ID# 1116-0560
🇧🇪Gent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 1116-0559
🇧🇪Leuven, Vlaams-Brabant, Belgium
Tom Baker Cancer Centre /ID# 1116-0157
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute /ID# 1116-0018
🇨🇦Edmonton, Alberta, Canada
Beijing Cancer Hospital /ID# 1116-0670
🇨🇳Beijing, Beijing, China
Peking University Third Hospital /ID# 1116-0673
🇨🇳Beijing, Beijing, China
Jiangsu Province Hospital /ID# 1116-0671
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 1116-0675
🇨🇳Hangzhou, Zhejiang, China
Fakultni nemocnice Brno /ID# 1116-0562
🇨🇿Brno, Czechia
Fakultni nemocnice Hradec Kralove /ID# 1116-0564
🇨🇿Hradec Kralove, Czechia
Fakultni nemocnice Plzen /ID# 1116-0566
🇨🇿Plzen, Czechia
St James Hospital /ID# 1116-0570
🇮🇪Dublin 8, Dublin, Ireland
University Hospital Galway /ID# 1116-0571
🇮🇪Galway, Ireland
Rambam Health Care Campus /ID# 1116-0576
🇮🇱Haifa, H_efa, Israel
Bnai Zion Medical Center /ID# 1116-0573
🇮🇱Haifa, H_efa, Israel
Rabin Medical Center /ID# 1116-0575
🇮🇱Haifa, H_efa, Israel
Galilee Medical Center /ID# 1116-0578
🇮🇱Nahariya, HaTsafon, Israel
Shaare Zedek Medical Center /ID# 1116-0577
🇮🇱Jerusalem, Yerushalayim, Israel
Tel Aviv Sourasky Medical Center /ID# 1116-0856
🇮🇱Tel Aviv-Yafo, Israel
Institute of Hematology Seràgnoli /ID# 1116-0580
🇮🇹Bologna, Emilia-Romagna, Italy
Ospedale San Raffaele IRCCS /ID# 1116-0523
🇮🇹Milan, Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 1116-0581
🇮🇹Milan, Milano, Italy
Università La Sapienza /ID# 1116-0583
🇮🇹Rome, Roma, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 1116-0584
🇮🇹Milan, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 1116-0524
🇮🇹Modena, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 1116-0582
🇮🇹Novara, Italy
Universita degli Studi di Padova /ID# 1116-0527
🇮🇹Padova, Italy
Policlinico Universitario A Gemelli /ID# 1116-0891
🇮🇹Rome, Italy
Auckland City Hospital /ID# 1116-0588
🇳🇿Grafton, Auckland, New Zealand
North Shore Hospital /ID# 1116-0663
🇳🇿Takapuna, Auckland, New Zealand
Haematology Waikato Hospital /ID# 1116-0586
🇳🇿Hamilton, Waikato, New Zealand
Wellington Blood and Cancer Centre /ID# 1116-0587
🇳🇿Wellington South, Wellington, New Zealand
Canterbury Health Labs Canterbury Disrict Health Board /ID# 1116-0589
🇳🇿Christchurch, New Zealand
MTZ Clinical Research Sp. z o.o. /ID# 1116-0363
🇵🇱Warszawa, Mazowieckie, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. /ID# 1116-0592
🇵🇱Brzozow, Podkarpackie, Poland
Samodzielny Publiczny Szpital Klinczny Nr-1- Akademickie Cenrum Klinic /ID# 1116-0529
🇵🇱Gdańsk, Pomorskie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 1116-0591
🇵🇱Chorzow, Slaskie, Poland
Medical Univ. of Lodz and Copernicus Memorial Hospital /ID# 1116-0531
🇵🇱Lodz, Poland
State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 1116-0707
🇷🇺Ryazan, Ryazanskaya Oblast, Russian Federation
Hospital Duran i Reynals /ID# 1116-0604
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 1116-0536
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario Vall d'Hebron /ID# 1116-0534
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona /ID# 1116-0533
🇪🇸Barcelona, Spain
Ic Hastaliklari Anabilim Dali/Ege University Medical Faculty /ID# 1116-0714
🇹🇷Izmir, Turkey
Dokuz Eylul University Medical Faculty /ID# 1116-0601
🇹🇷Izmir, Turkey
Erciyes Universiitesi Tip Fakultesi /ID# 1116-0602
🇹🇷Kayseri, Turkey
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 1116-0595
🇺🇦Vinnytsia, Vinnytska Oblast, Ukraine
Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 1116-0597
🇺🇦Cherkasy, Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 1116-0594
🇺🇦Dnipro, Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 1116-0596
🇺🇦Lviv, Ukraine
University Hospitals Dorset NHS Foundation Trust /ID# 1116-0551
🇬🇧Poole, Dorset, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 1116-0367
🇬🇧Southampton, Hampshire, United Kingdom
Nottingham University Hospitals NHS Trust /ID# 1116-0548
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 1116-0668
🇬🇧Oxford, Oxfordshire, United Kingdom
Cardiff & Vale University Health Board /ID# 1116-0607
🇬🇧Cardiff, Wales, United Kingdom
East Suffolk and North Essex NHS Foundation Trust /ID# 1116-0549
🇬🇧Colchester, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 1116-0550
🇬🇧Leeds, United Kingdom
King's College Hospital NHS Foundation Trust /ID# 1116-0544
🇬🇧London, United Kingdom