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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01724346




Registration number
NCT01724346
Ethics application status
Date submitted
2/11/2012
Date registered
9/11/2012
Date last updated
19/09/2024

Titles & IDs
Public title
Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Scientific 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)
Secondary ID [1] 0 0
2012-003968-44
Secondary ID [2] 0 0
PCYC-1116-CA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Small Lymphocytic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ibrutinib
Treatment: Drugs - Next-line ibrutinib

Experimental: Chlorambucil - 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).

Experimental: 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.


Treatment: Drugs: Ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily

Treatment: Drugs: Next-line ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Based on Investigator Assessment
Timepoint [1] 0 0
Median overall follow-up of 82.7 months
Secondary outcome [1] 0 0
Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2)
Timepoint [1] 0 0
Median overall follow-up of 82.7 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Median overall follow-up of 82.7 months
Secondary outcome [3] 0 0
Time to Next Treatment (TTNT)
Timepoint [3] 0 0
Median overall follow-up of 82.7 months
Secondary outcome [4] 0 0
Overall Response Rate (ORR)
Timepoint [4] 0 0
Median overall follow-up of 82.7 months
Secondary outcome [5] 0 0
Rate of Minimal Residual Disease (MRD) Negativity
Timepoint [5] 0 0
Median overall follow-up of 82.7 months
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
Median overall follow-up of 82.7 months

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2023
Sample size
Target
Accrual to date
Final
269
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
St George Hospital /ID# 1116-0654 - Kogarah
Recruitment hospital [2] 0 0
Princess Alexandra Hospital /ID# 1116-0503 - Woolloongabba
Recruitment hospital [3] 0 0
Flinders Medical Centre /ID# 1116-0163 - Bedford, Park
Recruitment hospital [4] 0 0
Royal Hobart /ID# 1116-0555 - Hobart
Recruitment hospital [5] 0 0
Box Hill Hospital /ID# 1116-0193 - Box Hill
Recruitment hospital [6] 0 0
Monash Medical Centre /ID# 1116-0556 - Clayton
Recruitment hospital [7] 0 0
St Vincent's Hospital Melbourne /ID# 1116-0501 - Fitzroy Melbourne
Recruitment hospital [8] 0 0
Austin Health /ID# 1116-0170 - Heidelberg
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5042 - Bedford, Park
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy Melbourne
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Belgium
State/province [13] 0 0
Antwerpen
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles-Capitale
Country [15] 0 0
Belgium
State/province [15] 0 0
Oost-Vlaanderen
Country [16] 0 0
Belgium
State/province [16] 0 0
Vlaams-Brabant
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
China
State/province [18] 0 0
Beijing
Country [19] 0 0
China
State/province [19] 0 0
Jiangsu
Country [20] 0 0
China
State/province [20] 0 0
Zhejiang
Country [21] 0 0
Czechia
State/province [21] 0 0
Brno
Country [22] 0 0
Czechia
State/province [22] 0 0
Hradec Kralove
Country [23] 0 0
Czechia
State/province [23] 0 0
Plzen
Country [24] 0 0
Ireland
State/province [24] 0 0
Dublin
Country [25] 0 0
Ireland
State/province [25] 0 0
Galway
Country [26] 0 0
Israel
State/province [26] 0 0
H_efa
Country [27] 0 0
Israel
State/province [27] 0 0
HaTsafon
Country [28] 0 0
Israel
State/province [28] 0 0
Yerushalayim
Country [29] 0 0
Israel
State/province [29] 0 0
Tel Aviv-Yafo
Country [30] 0 0
Italy
State/province [30] 0 0
Emilia-Romagna
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Italy
State/province [33] 0 0
Milan
Country [34] 0 0
Italy
State/province [34] 0 0
Modena
Country [35] 0 0
Italy
State/province [35] 0 0
Novara
Country [36] 0 0
Italy
State/province [36] 0 0
Padova
Country [37] 0 0
Italy
State/province [37] 0 0
Rome
Country [38] 0 0
New Zealand
State/province [38] 0 0
Auckland
Country [39] 0 0
New Zealand
State/province [39] 0 0
Waikato
Country [40] 0 0
New Zealand
State/province [40] 0 0
Wellington
Country [41] 0 0
New Zealand
State/province [41] 0 0
Christchurch
Country [42] 0 0
Poland
State/province [42] 0 0
Mazowieckie
Country [43] 0 0
Poland
State/province [43] 0 0
Podkarpackie
Country [44] 0 0
Poland
State/province [44] 0 0
Pomorskie
Country [45] 0 0
Poland
State/province [45] 0 0
Slaskie
Country [46] 0 0
Poland
State/province [46] 0 0
Lodz
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Ryazanskaya Oblast
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Turkey
State/province [50] 0 0
Ankara
Country [51] 0 0
Turkey
State/province [51] 0 0
Izmir
Country [52] 0 0
Turkey
State/province [52] 0 0
Kayseri
Country [53] 0 0
Ukraine
State/province [53] 0 0
Vinnytska Oblast
Country [54] 0 0
Ukraine
State/province [54] 0 0
Cherkasy
Country [55] 0 0
Ukraine
State/province [55] 0 0
Dnipro
Country [56] 0 0
Ukraine
State/province [56] 0 0
Lviv
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Dorset
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Hampshire
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Nottinghamshire
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Oxfordshire
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Wales
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Colchester
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Leeds
Country [64] 0 0
United Kingdom
State/province [64] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pharmacyclics LLC.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Janssen Research & Development, LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/study/NCT01724346
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01724346