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

Sponsor
Pharmacyclics LLC. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01724346
Collaborator
Janssen Research & Development, LLC (Industry)
232
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2.2
0

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Post-Chlorambucil Therapy Follow-up
  • Drug: Ibrutinib
  • Drug: Second-line Ibrutinib
  • Drug: Alternative Anticancer Treatment
  • Drug: Alternative Anti-cancer Treatment
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
232 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Masking Description:
Open label study
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Aug 28, 2012
Anticipated Primary Completion Date :
Apr 3, 2023
Anticipated Study Completion Date :
Apr 3, 2023

Arms and Interventions

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: Ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.
Other Names:
  • PCI-32765
  • Drug: Alternative Anticancer Treatment
    Specific therapy and treatment regimen are at the Investigator's discretion.

    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: 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
  • Drug: Alternative Anticancer Treatment
    Specific therapy and treatment regimen are at the Investigator's discretion.

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival (PFS) [10 years]

      To monitor progression-free survival (PFS)

    2. Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA [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

    3. Long-term follow-up and Second-line therapy monitoring [10 years]

      To follow patients for long-term outcome

    4. Efficacy evaluation of subsequent therapy [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Pharmacyclics LLC.
    • Janssen Research & Development, LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pharmacyclics LLC.
    ClinicalTrials.gov Identifier:
    NCT01724346
    Other Study ID Numbers:
    • PCYC-1116-CA
    • 2012-003968-44
    First Posted:
    Nov 9, 2012
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pharmacyclics LLC.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2022