AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 3NCT01722487

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

A Phase 3 study testing Ibrutinib and Chlorambucil in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Pharmacyclics LLC. at 108 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Ibrutinib and Chlorambucil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
108 sitesin 16 countries
Study dates
Mar 2013to May 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Males or females of 65 years of age or greater. Patients between the ages of 65 and 70 years of age must have 1 or more of the following comorbidities that may preclude the use of frontline chemo-immunotherapy with fludarabine, cyclophosphamide, or rituximab:
  • creatinine clearance < 70 mL/min using the Cockcroft-Gault equation
  • platelet count < 100,000/μL or hemoglobin < 10 g/dL
  • clinically apparent autoimmune cytopenia (autoimmune hemolytic anemia or immune thrombocytopenia)
  • ECOG performance score = 1 or 2
  • Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria (Hallek 2008)
Show all 21Show fewer
  • Active disease meeting at least 1 of the following IWCLL criteria (Hallek 2008) for requiring treatment:
  • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia Massive, progressive, or symptomatic splenomegaly
  • Massive nodes or progressive or symptomatic lymphadenopathy
  • Progressive lymphocytosis
  • Autoimmune hemolytic anemia and/or immune thrombocytopenia that is poorly responsive to corticosteroids or standard therapy
  • Constitutional symptoms
  • Measurable nodal disease by computed tomography (CT)
  • ECOG performance status of 0-2
  • Life expectancy > 4 months from randomization
  • Adequate hematologic function, defined as absolute neutrophil count (ANC) ≥ 1,000/μL (independent of growth factor support for at least 7 days prior to screening) and platelet count ≥ 50,000/μL (independent of transfusion and growth factor support for at least 7 days prior to screening)
  • Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 x upper limit of normal (ULN), and total bilirubin ≤ 1.5 x ULN
  • Adequate renal function, defined as estimated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
  • Willingness to receive all outpatient treatment, all laboratory monitoring, and all radiological evaluations at the institution that administers study drug for the entire study
  • Willingness of male patients, if sexually active with a female of childbearing potential, to use an effective barrier method of contraception during the study and for 3 months following the last dose of study drug
  • Ability to provide written informed consent and to understand and comply with the requirements of the study

Who cannot join

  • Known involvement of the central nervous system by lymphoma or leukemia
  • History or current evidence of Richter's transformation or prolymphocytic leukemia
  • Documentation of deletion of the short arm of chromosome 17: del(17p13.1) in more than 20% of cells examined on any pretreatment fluorescence in situ hybridization (FISH) or cytogenetic evaluation
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
  • Any previous treatment (chemotherapy, radiotherapy, and/or monoclonal antibodies) intended specifically to treat CLL/SLL
  • Received any immunotherapy, vaccine, or investigational drug within 4 weeks prior to randomization
Show all 21Show fewer
  • Corticosteroid use within 1 week prior to first dose of study drug, with the exception of inhaled, topical, or other local administrations. Patients requiring systemic steroids at daily doses > 20 mg prednisone (or corticosteroid equivalent, see Appendix N), or those who are administered steroids for leukemia control or white blood cell (WBC)-count-lowering are excluded.
  • Major surgery within 4 weeks prior to randomization
  • History of prior malignancy, with the exception of the following:
  • malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician
  • adequately treated nonmelanomatous skin cancer or lentigo maligna melanoma without current evidence of disease
  • adequately treated cervical carcinoma in situ without current evidence of disease
  • Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 6 months prior to randomization
  • Inability to swallow capsules or tablets, or disease significantly affecting gastrointestinal function
  • Uncontrolled active systemic fungal, bacterial, viral, or other infection or requirement for intravenous (IV) antibiotics
  • Known history of infection with human immunodeficiency virus (HIV)
  • Serologic status reflecting active hepatitis B or C infection
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment
  • Current life-threatening illness, medical condition, or organ-system dysfunction that could compromise patient safety or put the study at risk
  • Requirement for anticoagulation with warfarin
  • Requirement for treatment with a strong CYP3A4/5 and/or CYP2D6 inhibitor

Trial locations and contacts

108 sites in 16 countries.

108 sites in 16 countries

United States22 sites

  • Site Reference ID/Investigator #387

    Ann Arbor, Michigan, 48109

  • Site Reference ID/Investigator #125

    Atlanta, Georgia, 30318

  • Site Reference ID/Investigator #126

    Chicago, Illinois, 60637

  • Site Reference ID/Investigator #734

    Columbus, Ohio, 43219

  • Site Reference ID/Investigator #047

    Duarte, California, 91010

  • Site Reference ID/Investigator #656

    Goldsboro, North Carolina, 27534

  • Site Reference ID/Investigator #032

    Houston, Texas, 77030

  • Site Reference ID/Investigator #408

    La Jolla, California, 92093

  • Site Reference ID/Investigator #381

    Laredo, Texas, 78041

  • Site Reference ID/Investigator #712

    Las Vegas, Nevada, 89169

  • Site Reference ID/Investigator #071

    Louisville, Kentucky, 40207

  • Site Reference ID/Investigator #350

    New Hyde Park, New York, 11042

  • Site Reference ID/Investigator #050

    Pittsburgh, Pennsylvania, 15232

  • Site Reference ID/Investigator #677

    Portland, Oregon, 97227

  • Site Reference ID/Investigator #127

    Rochester, New York, 14642

  • Site Reference ID/Investigator #653

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator #720

    Santa Rosa, California, 95403

  • Site Reference ID/Investigator #404

    Seattle, Washington, 98109

  • Site Reference ID/Investigator #221

    St Louis, Missouri, 63110

  • Site Reference ID/Investigator #038

    Stanford, California, 94305

  • Site Reference ID/Investigator #731

    Walla Walla, Washington, 99362

  • Site Reference ID/Investigator #307

    Worcester, Massachusetts, 01655

Other trials in United States

Australia10 sites

  • Site Reference ID/Investigator #163

    Bedford Park, South Australia, 5042

  • Site Reference ID/Investigator #193

    Box Hill, Victoria, 3128

  • Site Reference ID/Investigator #556

    Clayton, Victoria, 3168

  • Site Reference ID/Investigator #501

    Fitzroy, Victoria, 3065

  • Site Reference ID/Investigator #715

    Frankston, Victoria, 3199

  • Site Reference ID/Investigator #558

    Geelong, Victoria, 3220

  • Site Reference ID/Investigator #170

    Heidelberg, Victoria, 3084

  • Site Reference ID/Investigator #555

    Hobart, Tasmania, 7000

  • Site Reference ID/Investigator #654

    Kogarah, New South Wales, 2217

  • Site Reference ID/Investigator #503

    Woolloongabba, Queensland, 4102

Other trials in Australia

Italy9 sites

  • Site Reference ID/Investigator #580

    Bologna, 40138

  • Site Reference ID/Investigator #584

    Milan, 20122

  • Site Reference ID/Investigator #523

    Milan, 20132

  • Site Reference ID/Investigator #581

    Milan, 20162

  • Site Reference ID/Investigator #524

    Modena, 41100

  • Site Reference ID/Investigator #582

    Novara, Piedmont, 28100

  • Site Reference ID/Investigator #527

    Padova, Veneto, 35128

  • Site Reference ID/Investigator #583

    Rome, Lazio, 00161

  • Site Reference ID/Investigator #522

    Rozzano, Milano, 20089

Other trials in Italy

United Kingdom9 sites

  • Site Reference ID/Investigator #721

    Birmingham, B9 5SS

  • Site Reference ID/Investigator #551

    Bournemouth, Dorset, BH7 7DW

  • Site Reference ID/Investigator #607

    Cardiff, South Glamergon, CF14 4XW

  • Site Reference ID/Investigator #549

    Colchester, Essex, CO4 5JL

  • Site Reference ID/Investigator #550

    Leeds, Yorkshire, LS9 7TF

  • Site Reference ID/Investigator #544

    London, England, SE5 9RS

  • Site Reference ID/Investigator #548

    Nottingham, NG5 1PB

  • Site Reference ID/Investigator #668

    Oxford, England, OX3 7LE

  • Site Reference ID/Investigator #367

    Southampton, SO16 6YD

Other trials in United Kingdom

Belgium7 sites

  • Site Reference ID/Investigator #561

    Antwerp, 2060

  • Site Reference ID/Investigator #628

    Bruges, West-Vlaanderen, 8000

  • Site Reference ID/Investigator #184

    Brussells, 1000

  • Site Reference ID/Investigator #164

    Brussels, Brussells, 1200

  • Site Reference ID/Investigator #560

    Ghent, Oost-Vlaanderen, 9000

  • Site Reference ID/Investigator #559

    Leuven, Vlaams Brabant, 3000

  • Site Reference ID/Investigator #727

    Yvoir, Namur, 5530

Other trials in Belgium

Ukraine7 sites

  • Site Reference ID/Investigator #597

    Cherkasy, Cherkasy Oblast, 18009

  • Site Reference ID/Investigator #594

    Dnipropetrovsk, Dnipropetrovsk Oblast, 49102

  • Site Reference ID/Investigator #725

    Kharkiv, Kharkiv Oblast, 61070

  • Site Reference ID/Investigator #596

    Lviv, Lviv Oblast, 79044

  • Site Reference ID/Investigator #598

    Simferopol, Autonomous Republic of Crimea, 95023

  • Site Reference ID/Investigator #595

    Vinnytsia, Vinnytsia Oblast, 21018

  • Site Reference ID/Investigator #724

    Zhytomyr, Zhytomyr Oblast, 10022

Other trials in Ukraine

Israel6 sites

  • Site Reference ID/Investigator #573

    Haifa, 31048

  • Site Reference ID/Investigator #576

    Haifa, 31096

  • Site Reference ID/Investigator #577

    Jerusalem, 91031

  • Site Reference ID/Investigator #578

    Nahariya, 22100

  • Site Reference ID/Investigator #575

    Petah Tikva, 49100

  • Site Reference ID/Investigator #574

    Ramat Gan, 52621

Other trials in Israel

Spain6 sites

  • Site Reference ID/Investigator #534

    Barcelona, 08035

  • Site Reference ID/Investigator #533

    Barcelona, 08036

  • Site Reference ID/Investigator #535

    Barcelona, 08041

  • Site Reference ID/Investigator #604

    Barcelona, 08908

  • Site Reference ID/Investigator #537

    Madrid, 28050

  • Site Reference ID/Investigator #536

    Majadahonda, Madrid, 28222

Other trials in Spain

Turkey (Türkiye)6 sites

  • Site Reference ID/Investigator #608

    Ankara, 06500

  • Site Reference ID/Investigator #606

    Ankara, 06590

  • Site Reference ID/Investigator #599

    Istanbul, 34390

  • Site Reference ID/Investigator #714

    Izmir, 35040

  • Site Reference ID/Investigator #601

    Izmir, 35340

  • Site Reference ID/Investigator #602

    Kayseri, 38039

Other trials in Turkey (Türkiye)

China5 sites

  • Site Reference ID/Investigator #670

    Beijing, 100142

  • Site Reference ID/Investigator #673

    Beijing, 100191

  • Site Reference ID/Investigator #674

    Guangzhou, Guangdong, 510060

  • Site Reference ID/Investigator #675

    Hangzhou, Zhejiang, 31003

  • Site Reference ID/Investigator #671

    Nanjing, Jiangsu, 210029

Other trials in China

New Zealand5 sites

  • Site Reference ID/Investigator #663

    Auckland, 0622

  • Site Reference ID/Investigator #588

    Auckland, 1023

  • Site Reference ID/Investigator #589

    Christchurch, Canterbury, 8011

  • Site Reference ID/Investigator #586

    Hamilton, Waikato Region, 3240

  • Site Reference ID/Investigator #587

    Wellington, 6021

Other trials in New Zealand

Poland5 sites

  • Site Reference ID/Investigator #592

    Brzozowie, Podkarpackie Voivodeship, 36.200

  • Site Reference ID/Investigator #591

    Chorzów, 40

  • Site Reference ID/Investigator #529

    Gdansk, 80-952

  • Site Reference ID/Investigator #531

    Lodz, 93-510

  • Site Reference ID/Investigator #590

    Lublin, Lublin Voivodeship, 20-081

Other trials in Poland

Canada3 sites

  • Site Reference ID/Investigator #157

    Calgary, Alberta, T2N 4N2

  • Site Reference ID/Investigator #018

    Edmonton, Alberta, T6G 1Z2

  • Site Reference ID/Investigator #159

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Czechia3 sites

  • Site Reference ID/Investigator #562

    Brno, 625 00

  • Site Reference ID/Investigator #564

    Hradec Králové, Hradec Králové Region, 500 05

  • Site Reference ID/Investigator #566

    Plzen-Lochotin, 304 60

Other trials in Czechia

Ireland3 sites

  • Site Reference ID/Investigator #572

    Dublin, 7

  • Site Reference ID/Investigator #570

    Dublin, 8

  • Site Reference ID/Investigator #571

    Galway, ST4 6QG

Other trials in Ireland

Russia2 sites

  • Site Reference ID/Investigator #707

    Ryazan, 390039

  • Site Reference ID/Investigator #304

    Yaroslavl, 150062

Other trials in Russia

About this study

Official title: Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

Read the detailed description

Study design: This is a randomized, multicenter, open-label, Phase 3 study designed to compare the safety and efficacy of Ibrutinib versus Chlorambucil in treatment-naive patients 65 years or older who have CLL or SLL.

Eligible patients will be randomized in a 1:1 ratio to Treatment Arm A or B:

  • Treatment Arm A: Oral Chlorambucil 0.5 mg/kg on Days 1 and 15 of each 28-day cycle; the dose can be increased, if well tolerated, in increments of 0.1 mg/kg on Day 1 of each cycle to a maximum of 0.8 mg/kg; patients receive a minimum of 3 and a maximum of 12 cycles, in the absence of progressive disease or unacceptable toxicity.
  • Treatment Arm B: Oral Ibrutinib 420 mg/day Randomization will be stratified on Eastern Cooperative Oncology Group (ECOG) performance status (0,1 versus 2); presence of advanced Rai stage (yes/no), advanced being defined as Stages 3-4; and geographic region: US versus non-US.
Being tested
Ibrutinib, Chlorambucil
Keywords
CLL, SLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbrutinibDrug

    Ibrutinib will be supplied as hard gelatin 140-mg capsules for oral (PO) administration. Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis. Ibrutinib will be dispensed to patients in bottles at each visit.

  • ChlorambucilDrug

    Chlorambucil will be supplied as 2-mg tablets for PO administration. Chlorambucil is administered orally on Days 1 and 15 of each 28-day cycle. The starting dosage (Cycle 1) is 0.5 mg/kg. If well tolerated, the Chlorambucil dose can be increased starting at Cycle 2, with increments of 0.1 mg/kg on Day 1 of each cycle to a maximum of 0.8 mg/kg.

Study groups in NCT01722487
Study groupRoleWhat they receive
IbrutinibExperimentalIbrutinib will be supplied as hard gelatin 140-mg capsules for oral (PO) administration. Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis. Ibrutinib will be dispensed to patients in bottles at each visit.
Receives: Drug: Ibrutinib
ChlorambucilActive comparatorChlorambucil will be supplied as 2-mg tablets for PO administration. Chlorambucil is administered orally on Days 1 and 15 of each 28-day cycle.The starting dosage (Cycle 1) is 0.5 mg/kg. If well tolerated, the Chlorambucil dose can be increased starting at Cycle 2, with increments of 0.1 mg/kg on Day 1 of each cycle to a maximum of 0.8 mg/kg.
Receives: Drug: Chlorambucil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS (Progression Free Survival)

    The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS

    Progressive disease according to 2008 IWCLL guidelines was defined as:

    • Group A
    • Lymphadenopathy, increase ≥50%
    • Hepatomegaly, increase ≥50%
    • Splenomegaly, increase ≥50%
    • Blood lymphocytes, increase ≥ 50% over baseline
    • Group B
    • Platelets counts, decrease of ≥ 50% from baseline secondary to CLL
    • Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL

    Measured: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.

Secondary outcomes (6)

  1. Overall Survival (OS)

    OS is calculated for all randomized subjects as the duration of time from the date of randomization to the date of death due to any cause or the date last known alive for subjects who were not known to have died at study closure.

    Measured: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.

  2. ORR (Overall Response Rate)

    ORR is defined as the proportion of subjects who achieved complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR per IRC assessment. Response criteria are as outlined in 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.

    Measured: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.

  3. Proportion of Sustained Hemoglobin Improvement

    The proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.

    Measured: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.

  4. Proportion of Sustained Hemoglobin Improvement in Subjects With Baseline Anemia

    In randomized subjects with baseline hemoglobin ≤ 11 g/dL, the proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.

    Measured: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.

  5. Proportion of Sustained Platelet Improvement

    The proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.

    Measured: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.

  6. Proportion of Sustained Platelet Improvement in Subjects With Baseline Thrombocytopenia

    In randomized subjects with baseline platelet ≤ 100 x 10^9/L, the proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline persisted continuously for ≥56 days (8 wee without blood transfusion or growth factors.

    Measured: Analysis was conducted when 15 months had elapsed after the last subject was randomized with cutoff date of 4 May 2015. The median follow-up time is 18 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2012 (estimated)
  2. Study startMar 2013
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01722487
Sponsor's protocol ID
PCYC-1115-CA
Other IDs
2012-003967-23
Status last verified
Oct 2017
First submitted
29 Oct 2012
Last updated
30 Nov 2017
Data monitoring committee
No
Individual data sharing
No: We share this information with FDA and other authorities for the purposes of analyzing the study but not with other researchers

Publications

  • Abuhelwa AY, Almansour SA, Brown JR, Al-Shamsi HO, Abuhelwa Z, Kharaba Z, Bustanji Y, Semreen MH, Ali S, Alhuraiji A, McKinnon RA, Sorich MJ, Alzoubi KH, Hopkins AM. Statin use and survival in CLL/SLL treated with ibrutinib: pooled analysis of 4 randomized controlled trials. Blood Adv. 2025 Jul 22;9(14):3566-3575. doi: 10.1182/bloodadvances.2024015287.

    PubMed 40266025

  • Barr PM, Owen C, Robak T, Tedeschi A, Bairey O, Burger JA, Hillmen P, Dearden C, Grosicki S, McCarthy H, Li JY, Offner F, Moreno C, Jermain M, Zhou C, Hsu E, Szoke A, Kipps TJ, Ghia P. Many People With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Benefit From Ibrutinib Treatment Up To 8 Years: A Plain Language Summary. Future Oncol. 2023 Jan 9. doi: 10.2217/fon-2022-0898. Online ahead of print.

    PubMed 36617990

  • 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.

    PubMed 35377947

  • Burger JA, Robak T, Demirkan F, Bairey O, Moreno C, Simpson D, Munir T, Stevens DA, Dai S, Cheung LWK, Kwei K, Lal I, Hsu E, Kipps TJ, Tedeschi A. Up to 6.5 years (median 4 years) of follow-up of first-line ibrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and high-risk genomic features: integrated analysis of two phase 3 studies. Leuk Lymphoma. 2022 Jun;63(6):1375-1386. doi: 10.1080/10428194.2021.2020779. Epub 2022 Jan 11.

    PubMed 35014928

  • Allan JN, Shanafelt T, Wiestner A, Moreno C, O'Brien SM, Li J, Krigsfeld G, Dean JP, Ahn IE. Long-term efficacy of first-line ibrutinib treatment for chronic lymphocytic leukaemia in patients with TP53 aberrations: a pooled analysis from four clinical trials. Br J Haematol. 2022 Feb;196(4):947-953. doi: 10.1111/bjh.17984. Epub 2021 Dec 5.

    PubMed 34865212

  • 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.

    PubMed 31196847

  • 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.

    PubMed 29880603

  • Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.

    PubMed 28751558

  • Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, O'Dwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ; RESONATE-2 Investigators. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015 Dec 17;373(25):2425-37. doi: 10.1056/NEJMoa1509388. Epub 2015 Dec 6.

    PubMed 26639149

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibrutinib and Chlorambucil in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Pharmacyclics LLC. at 108 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Australia, Italy, United Kingdom, Belgium and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (Progression Free Survival) (time frame: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01722487, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.

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