Trial record 1 of 1 for:    NCT01724346
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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)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01724346
First received: November 2, 2012
Last updated: February 13, 2014
Last verified: December 2013
  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:


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.

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:

  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:

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

ClinicalTrials.gov processed this record on July 31, 2014