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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01724346
Recruitment Status : Active, not recruiting
First Posted : November 9, 2012
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

Tracking Information
First Submitted Date  ICMJE November 2, 2012
First Posted Date  ICMJE November 9, 2012
Last Update Posted Date August 3, 2020
Actual Study Start Date  ICMJE August 28, 2012
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Progression-free Survival (PFS) [ Time Frame: 10 years ]
    To monitor progression-free survival (PFS)
  • 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
  • Long-term follow-up and Second-line therapy monitoring [ Time Frame: 10 years ]
    To follow patients for long-term outcome
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
PFS [ Time Frame: 5 years ]
  • Progression Free Survial on first-line therapy for those patients who did not experience PD in the parent study
  • Progression Free Survial on second-line anticancer therapy
  • Overall survival
  • For patients who discontinued first-line therapy, time from the end of firstline therapy to the beginning of second-line therapy
  • Overall Response Rate, DOR, Progression Free Survial, and Overall survial on subsequent therapy for patients progressing in the parent study
  • Safety as measured by Grade 3, 4, 5 AEs, AEs leading to discontinuation, and serious adverse events (SAEs)
  • Disease outcome following cessation of PCI-32765 treatment after attainment of minimal residual disease (MRD)-negative remission in those patients receiving PCI-32765 as second-line therapy
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description:
Open label study
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Intervention  ICMJE
  • 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: Ibrutinib
    Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.
    Other Name: PCI-32765
  • 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 Name: PCI-32765
  • Drug: Alternative Anticancer Treatment
    Specific therapy and treatment regimen are at the Investigator's discretion.
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Post-Chlorambucil Therapy Follow-up
    • Drug: Alternative Anticancer Treatment
  • 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.
    Interventions:
    • Drug: Ibrutinib
    • Drug: Alternative Anticancer Treatment
  • 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.
    Interventions:
    • Drug: Second-line Ibrutinib
    • Drug: Alternative Anticancer Treatment
  • 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).
    Intervention: Drug: Alternative Anti-cancer Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 25, 2015)
232
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2012)
272
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   China,   Czechia,   Ireland,   Israel,   Italy,   New Zealand,   Poland,   Russian Federation,   Spain,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01724346
Other Study ID Numbers  ICMJE PCYC-1116-CA
2012-003968-44 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We share this information with FDA and other authorities for the purposes of analyzing the study but not with other researchers
Responsible Party Pharmacyclics LLC.
Study Sponsor  ICMJE Pharmacyclics LLC.
Collaborators  ICMJE Janssen Research & Development, LLC
Investigators  ICMJE
Study Director: Jim Dean, MD, PhD Pharmacyclics LLC.
PRS Account Pharmacyclics LLC.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP