Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

September 15, 2023 updated by: Pharmacyclics LLC.

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Site Reference ID/Investigator #654
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Site Reference ID/Investigator #503
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Site Reference ID/Investigator #163
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Site Reference ID/Investigator #555
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Site Reference ID/Investigator #193
      • Clayton, Victoria, Australia, 3168
        • Site Reference ID/Investigator #556
      • Fitzroy, Victoria, Australia, 3065
        • Site Reference ID/Investigator #501
      • Frankston, Victoria, Australia, 3199
        • Site Reference ID/Investigator #715
      • Geelong, Victoria, Australia, 3220
        • Site Reference ID/Investigator #558
      • Heidelberg, Victoria, Australia, 3084
        • Site Reference ID/Investigator #170
  • Belgium
      • Antwerpen, Belgium, 2060
        • Site Reference ID/Investigator #561
      • Brussells, Belgium, 1000
        • Site Reference ID/Investigator #184
    • Brussells
      • Bruxelles, Brussells, Belgium, 1200
        • Site Reference ID/Investigator #164
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Site Reference ID/Investigator #727
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Site Reference ID/Investigator #560
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Site Reference ID/Investigator #559
    • West-Vlaanderen
      • Brugge, West-Vlaanderen, Belgium, 8000
        • Site Reference ID/Investigator #628
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Site Reference ID/Investigator #157
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Site Reference ID/Investigator #018
  • China
      • Beijing, China, 100142
        • Site Reference ID/Investigator #670
      • Beijing, China, 100191
        • Site Reference ID/Investigator #673
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Site Reference ID/Investigator #674
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Site Reference ID/Investigator #671
    • Zhejiang
      • Hangzhou, Zhejiang, China, 31003
        • Site Reference ID/Investigator #675
  • Czechia
      • Brno, Czechia, 625 00
        • Site Reference ID/Investigator #562
      • Plzen-Lochotin, Czechia, 304 60
        • Site Reference ID/Investigator #566
    • Kralovehradecky Kraj
      • Hradec Kralove, Kralovehradecky Kraj, Czechia, 500 05
        • Site Reference ID/Investigator #564
  • Ireland
      • Dublin, Ireland, 7
        • Site Reference ID/Investigator #572
      • Dublin, Ireland, 8
        • Site Reference ID/Investigator #570
      • Galway, Ireland, ST4 6QG
        • Site Reference ID/Investigator #571
  • Israel
      • Haifa, Israel, 31048
        • Site Reference ID/Investigator #573
      • Haifa, Israel, 31096
        • Site Reference ID/Investigator #576
      • Jerusalem, Israel, 91031
        • Site Reference ID/Investigator #577
      • Nahariya, Israel, 22100
        • Site Reference ID/Investigator #578
      • Petaẖ Tiqwa, Israel, 49100
        • Site Reference ID/Investigator #575
      • Ramat Gan, Israel, 52621
        • Site Reference ID/Investigator #574
  • Italy
      • Bologna, Italy, 40138
        • Site Reference ID/Investigator #580
      • Milano, Italy, 20122
        • Site Reference ID/Investigator #584
      • Milano, Italy, 20132
        • Site Reference ID/Investigator #523
      • Milano, Italy, 20162
        • Site Reference ID/Investigator #581
      • Modena, Italy, 41100
        • Site Reference ID/Investigator #524
    • Lazio
      • Roma, Lazio, Italy, 00161
        • Site Reference ID/Investigator #583
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Site Reference ID/Investigator #522
    • Piemonte
      • Novara, Piemonte, Italy, 28100
        • Site Reference ID/Investigator #582
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Site Reference ID/Investigator #527
  • New Zealand
      • Auckland, New Zealand, 0622
        • Site Reference ID/Investigator #663
      • Auckland, New Zealand, 1023
        • Site Reference ID/Investigator #588
      • Wellington, New Zealand, 6021
        • Site Reference ID/Investigator #587
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Site Reference ID/Investigator #589
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Site Reference ID/Investigator #586
  • Poland
      • Chorzow, Poland, 40
        • Site Reference ID/Investigator #591
      • Gdansk, Poland, 80-952
        • Site Reference ID/Investigator #529
      • Lodz, Poland, 93-510
        • Site Reference ID/Investigator #531
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-081
        • Site Reference ID/Investigator #590
    • Podkarpackie
      • Brzozowie, Podkarpackie, Poland, 36.200
        • Site Reference ID/Investigator #592
  • Russian Federation
      • Ryazan, Russian Federation, 390039
        • Site Reference ID/Investigator #707
      • Yaroslavl, Russian Federation, 150062
        • Site Reference ID/Investigator #304
  • Spain
      • Barcelona, Spain, 08035
        • Site Reference ID/Investigator #534
      • Barcelona, Spain, 08036
        • Site Reference ID/Investigator #533
      • Barcelona, Spain, 08041
        • Site Reference ID/Investigator #535
      • Barcelona, Spain, 08908
        • Site Reference ID/Investigator #604
      • Madrid, Spain, 28050
        • Site Reference ID/Investigator #537
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Site Reference ID/Investigator #536
  • Turkey
      • Ankara, Turkey, 06500
        • Site Reference ID/Investigator #608
      • Ankara, Turkey, 06590
        • Site Reference ID/Investigator #606
      • Istanbul, Turkey, 34390
        • Site Reference ID/Investigator #599
      • Izmir, Turkey, 35040
        • Site Reference ID/Investigator #714
      • Izmir, Turkey, 35340
        • Site Reference ID/Investigator #601
      • Kayseri, Turkey, 38039
        • Site Reference ID/Investigator #602
  • Ukraine
    • Cherkas'ka Oblast
      • Cherkasy, Cherkas'ka Oblast, Ukraine, 18009
        • Site Reference ID/Investigator #597
    • Dnipropetrovs'ka Oblast'
      • Dnipropetrovsk, Dnipropetrovs'ka Oblast', Ukraine, 49102
        • Site Reference ID/Investigator #594
    • Kharkivs'ka Oblast
      • Kharkiv, Kharkivs'ka Oblast, Ukraine, 61070
        • Site Reference ID/Investigator #725
    • L'vivs'ka Oblast
      • Lviv, L'vivs'ka Oblast, Ukraine, 79044
        • Site Reference ID/Investigator #596
    • Respublika Krym
      • Simferopol, Respublika Krym, Ukraine, 95023
        • Site Reference ID/Investigator #598
    • Vinnyts'ka Oblast
      • Vinnytsia, Vinnyts'ka Oblast, Ukraine, 21018
        • Site Reference ID/Investigator #595
    • Zhytomyrs'ka Oblast'
      • Zhytomyr, Zhytomyrs'ka Oblast', Ukraine, 10022
        • Site Reference ID/Investigator #724
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Site Reference ID/Investigator #721
      • Nottingham, United Kingdom, NG5 1PB
        • Site Reference ID/Investigator #548
      • Southampton, United Kingdom, SO16 6YD
        • Site Reference ID/Investigator #367
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Site Reference ID/Investigator #551
    • England
      • London, England, United Kingdom, SE5 9RS
        • Site Reference ID/Investigator #544
      • Oxford, England, United Kingdom, OX3 7LE
        • Site Reference ID/Investigator #668
    • Essex
      • Colchester, Essex, United Kingdom, CO4 5JL
        • Site Reference ID/Investigator #549
    • South Glamergon
      • Cardiff, South Glamergon, United Kingdom, CF14 4XW
        • Site Reference ID/Investigator #607
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS9 7TF
        • Site Reference ID/Investigator #550
  • United States
    • California
      • Duarte, California, United States, 91010
        • Site Reference ID/Investigator #047
      • La Jolla, California, United States, 92093
        • Site Reference ID/Investigator #408
      • Santa Rosa, California, United States, 95403
        • Site Reference ID/Investigator #720
      • Stanford, California, United States, 94305
        • Site Reference ID/Investigator #038
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Site Reference ID/Investigator #125
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Site Reference ID/Investigator #126
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Site Reference ID/Investigator #071
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Site Reference ID/Investigator #307
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Site Reference ID/Investigator #387
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Site Reference ID/Investigator #221
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Site Reference ID/Investigator #712
    • New York
      • New Hyde Park, New York, United States, 11042
        • Site Reference ID/Investigator #350
      • Rochester, New York, United States, 14642
        • Site Reference ID/Investigator #127
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Site Reference ID/Investigator #656
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Site Reference ID/Investigator #734
    • Oregon
      • Portland, Oregon, United States, 97227
        • Site Reference ID/Investigator #677
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Site Reference ID/Investigator #050
    • Texas
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator #032
      • Laredo, Texas, United States, 78041
        • Site Reference ID/Investigator #381
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator #653
    • Washington
      • Seattle, Washington, United States, 98109
        • Site Reference ID/Investigator #404
      • Walla Walla, Washington, United States, 99362
        • Site Reference ID/Investigator #731

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Randomized in the parent study, PCYC-1115-CA
  2. Informed consent for Study PCYC-1116-CA
  3. IRC-confirmed 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm A Post-Chlorambucil Therapy Followup
Patients randomized to Chlorambucil in the parent study(PCYC-1115-CA) who have not progressed at the time of parent study closure will be transferred to this Arm. Follow-up will continue until PD, unacceptable toxicity, or other reason for treatment discontinuation.
Drug: Post-Chlorambucil Therapy Follow-up
Patients remain in this Arm for continued follow-up until PD, unacceptable toxicity, or other reason for treatment discontinuation. All patients in this Arm have completed Chlorambucil therapy. Patients who have progression will exit the study.
Drug: Alternative Anticancer Treatment
Specific therapy and treatment regimen are at the Investigator's discretion.
Experimental: Arm B Ibrutinib
Patients randomized to Ibrutinib in the parent study (PCYC-1115-CA) who have not experienced PD at the time of parent study closure will be transferred to this Arm to continue on Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.
Drug: Alternative Anticancer Treatment
Specific therapy and treatment regimen are at the Investigator's discretion.
Drug: Ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.
Other Names:
  • PCI-32765
Experimental: Arm C Second-line Ibrutinib
Patients who received Chlorambucil in the parent study (PCYC-1115-CA) and experienced PD are transferred to this Arm for Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.
Drug: Alternative Anticancer Treatment
Specific therapy and treatment regimen are at the Investigator's discretion.
Drug: Second-line Ibrutinib
Patients in this arm who were previously eligible to receive Second-line Ibrutinib will exit the study with option to roll-over to another long-term Ibrutinib study, if eligible.
Other Names:
  • PCI-32765
Other: Arm D Alternative Anticancer Therapy
At the Investigator's discretion, alternative anticancer treatment is a therapeutic option for patients who experienced PD during Ibrutinib treatment or during or after Chlorambucil treatment. This Arm can also be considered if drug is discontinued for other reasons (e.g., intolerability or adverse event [AE]) or prior to experiencing PD).
Drug: Alternative Anti-cancer Treatment
Specific therapy and treatment regimen are at the Investigator's discretion. Patients originally randomized to Chlorambucil will exit the study. Patients originally randomized to Ibrutinib will continue on study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: 10 years
To monitor progression-free survival (PFS)
10 years
Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA
Time Frame: 10 years
To continue treatment and safety assessment of patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA (the parent study) who have not progressed at the time of parent study closure
10 years
Long-term follow-up and Second-line therapy monitoring
Time Frame: 10 years
To follow patients for long-term outcome
10 years
Efficacy evaluation of subsequent therapy
Time Frame: 10 years
To capture overall response rate (ORR), duration of response (DOR), PFS, and overall survival (OS) to subsequent therapy, and time to next therapy, in patients progressing in the parent study
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Collaborators

Janssen Research & Development, LLC

Investigators

  • Study Director: Jim Dean, MD, PhD, Pharmacyclics LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2012

Primary Completion (Actual)

August 17, 2023

Study Completion (Actual)

August 17, 2023

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (Estimated)

November 9, 2012

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-1116-CA
  • 2012-003968-44 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We share this information with FDA and other authorities for the purposes of analyzing the study but not with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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