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

Completed · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

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)

Key facts

Study ID

NCT01724346

Run by

Pharmacyclics LLC.

People needed

269

Starts

2013-12-03

Expected to finish

2023-08-18

Last updated by the study team

2024-09-19

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Randomized in the parent study, PCYC-1115-CA
• Informed consent for Study PCYC-1116-CA
• Independent review committee (IRC)-confirmed disease progression (PD) in the parent study PCYC-1115-CA or closure of the parent study

You may not qualify if…

• Disease progression involving the central nervous system (CNS) or transformation to another histology
• Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease
• In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug
• Requirement for treatment with a strong CYP3A inhibitor
• Uncontrolled systemic infection or requirement for IV antibiotics
• Noncompliance on the parent study(PCYC-1115-CA)

Where it is running

• Moores Cancer Center at UC San Diego /ID# 1116-0408 — La Jolla, California, United States
• Stanford University/Stanford Cancer Center, Campus Drive /ID# 1116-0038 — Stanford, California, United States
• University of Chicago /ID# 1116-0126 — Chicago, Illinois, United States
• Norton Cancer Institute - St Matthews /ID# 1116-0071 — Louisville, Kentucky, United States
• Comprehensive Cancer Centers of Nevada /ID# 1116-0712 — Henderson, Louisiana, United States
• University of Massachusetts - Worcester /ID# 1116-0307 — Worcester, Massachusetts, United States
• Washington University-School of Medicine /ID# 1116-0221 — St Louis, Missouri, United States
• Northwell Health/Long Island Jewish Hospital /ID# 1116-0350 — New Hyde Park, New York, United States
• University of Rochester Medical Center /ID# 1116-0127 — Rochester, New York, United States
• Southeastern Medical Oncology Center /ID# 1116-0656 — Goldsboro, North Carolina, United States
• Kaiser Permanente - Northwest /ID# 1116-0677 — Portland, Oregon, United States
• University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1116-0050 — Pittsburgh, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center /ID# 1116-0032 — Houston, Texas, United States
• Oncology of San Antonio /ID# 1116-0653 — San Antonio, Texas, United States
• Providence St. Mary Regional Cancer Center /ID# 1116-0731 — Walla Walla, Washington, United States
• St George Hospital /ID# 1116-0654 — Kogarah, New South Wales, Australia
• Princess Alexandra Hospital /ID# 1116-0503 — Woolloongabba, Queensland, Australia
• Flinders Medical Centre /ID# 1116-0163 — Bedford Park, South Australia, Australia
• Royal Hobart /ID# 1116-0555 — Hobart, Tasmania, Australia
• Box Hill Hospital /ID# 1116-0193 — Box Hill, Victoria, Australia
• Monash Medical Centre /ID# 1116-0556 — Clayton, Victoria, Australia
• St Vincent's Hospital Melbourne /ID# 1116-0501 — Fitzroy Melbourne, Victoria, Australia
• Austin Health /ID# 1116-0170 — Heidelberg, Victoria, Australia
• ZNA Cadix /ID# 1116-0561 — Antwerp, Antwerpen, Belgium
• City of Hope /ID# 1116-0047 — Duarte, California, United States

Full record on ClinicalTrials.gov

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