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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01724346
First received: November 2, 2012
Last updated: September 25, 2015
Last verified: September 2015
  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
Other: 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
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:
  • Progression-free Survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To monitor progression-free survival (PFS)

  • Safety assessment of patients randomized to Arm B (PCI-32765) in Study PCYC-1115-CA [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Follow-up
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.
Other: 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.
Drug: Second-line PCI-32765
For patients who experienced PD before other Second-line treatment are eligible to receive PCI-32765.
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.
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.
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
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:

  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
Janssen Research & Development, LLC
Investigators
Study Director: Lori Styles, MD Pharmacyclics
  More Information

Additional 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: September 25, 2015
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
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
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 08, 2016