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

Purpose

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 (PCI-32765 versus Chlorambucil)

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma	Drug: Arm A - Post-Chlorambucil Therapy Follow-up Drug: Arm B - PCI-32765 Drug: Second-line PCI-32765 Drug: Alternative Anticancer Treatment	Phase 3


Study Type:	Interventional
Study Design:	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 (PCI-32765 Versus Chlorambucil)

Resource links provided by NLM:

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia Lymphoma

Drug Information available for: Chlorambucil Ibrutinib

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic

U.S. FDA Resources

Further study details as provided by Pharmacyclics LLC.:

Primary Outcome Measures:

Progression-free Survival (PFS) [ Time Frame: 5 years ]
To monitor progression-free survival (PFS)
Safety as measured by all AEs and SAEs for patients randomized to Arm B (PCI-32765) in Study PCYC-1115-CA [ Time Frame: 5 years ]
To continue treatment and safety assessment of patients randomized to Arm B (PCI-32765) 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: 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
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


Enrollment:	232
Study Start Date:	January 2013
Estimated Study Completion Date:	February 2018
Estimated Primary Completion Date:	February 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: Arm A - 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. Other Name: Ibrutinib Drug: Second-line PCI-32765 For patients who experienced PD before other Second-line treatment are eligible to receive PCI-32765. Other Name: Ibrutinib Drug: Alternative Anticancer Treatment Specific therapy and treatment regimen are at the investigator's discretion.
Experimental: Arm B - PCI-32765 Patients randomized to PCI-32765 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 PCI-32765 treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.	Drug: Arm B - PCI-32765 PCI-32765 will be supplied as hard gelatin 140-mg capsules for oral (PO) administration. PCI-32765 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. PCI-32765 will be dispensed to patients in bottles at every other visit. Other Name: Ibrutinib Drug: Alternative Anticancer Treatment Specific therapy and treatment regimen are at the investigator's discretion.
Experimental: Second-line PCI-32765 Patients who received Chlorambucil in the parent study PCYC-1115-CA and experienced PD are transferred to this Arm for PCI-32765 treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.	Drug: Second-line PCI-32765 For patients who experienced PD before other Second-line treatment are eligible to receive PCI-32765. Other Name: Ibrutinib Drug: Alternative Anticancer Treatment Specific therapy and treatment regimen are at the investigator's discretion.
Alternative Anticancer Therapy At the investigator's discretion, alternative anticancer treatment is a therapeutic option for patients who experienced PD during PCI-32765 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.

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 PCI-32765 (for patients randomized to chlorambucil in the parent study who also meet the criteria for second-line PCI-32765 therapy), second-line chlorambucil (for patients randomized to PCI-32765 in the parent study), or other therapies.

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.

Eligibility


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

Criteria

Inclusion Criteria:

Randomized in the parent study, PCYC-1115-CA
Informed consent for Study PCYC-1116-CA
IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study

Exclusion Criteria:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724346

Show 108 Study Locations

Sponsors and Collaborators

Pharmacyclics LLC.

Janssen Research & Development, LLC

Investigators


Study Director:	Lori Styles, MD	Pharmacyclics LLC.

More Information

Additional Information:

www.pharmacyclics.com This link exits the ClinicalTrials.gov site


Responsible Party:	Pharmacyclics LLC.
ClinicalTrials.gov Identifier:	NCT01724346 History of Changes
Other Study ID Numbers:	PCYC-1116-CA 2012-003968-44 ( EudraCT Number )
Study First Received:	November 2, 2012
Last Updated:	April 3, 2017
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

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

ClinicalTrials.gov processed this record on September 21, 2017