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) - 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: PCI-32765	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label 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:

Genetics Home Reference related topics: head and neck squamous cell carcinoma

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia Lymphoma

Drug Information available for: Chlorambucil Ibrutinib

Genetic and Rare Diseases Information Center resources: Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Lymphosarcoma Squamous Cell Carcinoma of the Head and Neck

U.S. FDA Resources

Further study details as provided by Pharmacyclics:

Primary Outcome Measures:

PFS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- 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


Estimated Enrollment:	272
Study Start Date:	January 2013
Estimated Study Completion Date:	February 2018
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PCI-32765 Alternative anticancer treatment is selected at the investigator's discretion. For a patient randomized to chlorambucil in the parent study PCYC-1115-CA, PCI-32765 is an option for second-line therapy, provided the patient meets the criteria for second-line PCI-32765 therapy. For a patient randomized to PCI-32765 in the parent study PCYC-1115-CA, the patient will continue on PCI-32765 at the parent study.	Drug: 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.

Arms

Assigned Interventions

Experimental: PCI-32765

Alternative anticancer treatment is selected at the investigator's discretion. For a patient randomized to chlorambucil in the parent study PCYC-1115-CA, PCI-32765 is an option for second-line therapy, provided the patient meets the criteria for second-line PCI-32765 therapy. For a patient randomized to PCI-32765 in the parent study PCYC-1115-CA, the patient will continue on PCI-32765 at the parent study.

Drug: 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.

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
Genders Eligible for Study:	Both
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:

N/A

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

Locations


United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Pharmacyclics

Janssen Research & Development, LLC

Investigators


Study Director:	Lori Styles, MD	Pharmacyclics

More Information

No publications provided


Responsible Party:	Pharmacyclics
ClinicalTrials.gov Identifier:	NCT01724346 History of Changes
Other Study ID Numbers:	PCYC-1116-CA, 2012-003968-44
Study First Received:	November 2, 2012
Last Updated:	February 13, 2014
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada China: Food and Drug Administration Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Ireland: Irish Medicines Board Israel: Israeli Health Ministry Pharmaceutical Administration Italy: The Italian Medicines Agency New Zealand: Food Safety Authority Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Agencia Española de Medicamentos y Productos Sanitarios Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Pharmacyclics:


CLL, SLL

Additional relevant MeSH terms:


Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Immune System Diseases Immunoproliferative Disorders Leukemia, B-Cell Lymphatic Diseases Lymphoproliferative Disorders	Neoplasms Neoplasms by Histologic Type Chlorambucil Alkylating Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015