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

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ClinicalTrials.gov Identifier: NCT01724346
Recruitment Status : Active, not recruiting
First Posted : November 9, 2012
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

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
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: Post-Chlorambucil Therapy Follow-up Drug: Ibrutinib Drug: Second-line Ibrutinib Drug: Alternative Anticancer Treatment Phase 3

Detailed Description:

Study PCYC-1116-CA is an open-label, multicenter extension of Study PCYC 1115-CA (RESONATE™-2, the parent study), and it will run concurrently with the parent study. A patient will be transferred to PCYC-1116-CA after Independent Review Committee (IRC) confirmation of disease progression (PD) in the parent study or at closure of the parent study by the sponsor, whichever comes first.

After PD, selection of second-line therapy, when clinically indicated, is at the discretion of the investigator and can include second-line Ibrutinib (for patients randomized to chlorambucil in the parent study who also meet the criteria for second-line Ibrutinib therapy), second-line chlorambucil (for patients randomized to Ibrutinib in the parent study), other therapies, or no therapy.

Assessments in the extension study vary depending on the treatment to which the patient was randomized in the parent study, the disease-progression status at transfer to the extension study, and the planned treatment in the extension study.


Study Type : Interventional  (Clinical Trial)
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)
Study Start Date : August 28, 2012
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018


Arm Intervention/treatment
Arm A Post-Chlorambucil Therapy Followup
Patients randomized to Chlorambucil in the parent study, PCYC-1115-CA, and have not progressed at the time of the 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 continue follow-up until PD, unacceptable toxicity, or other reason for treatment discontinuation. All patients in this Arm have completed Chlorambucil therapy.

Drug: Second-line Ibrutinib
For patients who experienced PD before other Second-line treatment are eligible to receive Ibrutinib.

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 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 every other visit.

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
For patients who experienced PD before other Second-line treatment are eligible to receive Ibrutinib.

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

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 (eg., intolerability or adverse event [AE]) or prior to experiencing PD).
Drug: Alternative Anticancer Treatment
Specific therapy and treatment regimen are at the investigator's discretion.




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 5 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 [ Time Frame: 5 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 [ Time Frame: 5 years ]
    To follow patients for long-term outcome and allow second-line therapy to patients after progressing on their randomized therapy in the parent study

  4. Efficacy evaluation of subsequent therapy [ Time Frame: 5 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



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

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724346


  Show 107 Study Locations
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
Study Director: Jim Dean, MD Pharmacyclics LLC.

Additional Information:
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT01724346     History of Changes
Other Study ID Numbers: PCYC-1116-CA
2012-003968-44 ( EudraCT Number )
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pharmacyclics LLC.:
CLL, SLL

Additional relevant MeSH terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chlorambucil
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents