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

Part of paid clinical trials in Duarte, California.

Sponsor
Pharmacyclics LLC.
Study ID
NCT01724346
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily
  • Next-line ibrutinib — DRUG
    Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily

Study Details

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 Dates

Start date
Dec 3, 2013
Status verified
Aug 2024
Primary completion
Aug 18, 2023
Completion
Aug 18, 2023

Study Design

Enrollment
269 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chlorambucil
    Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after disease progression (PD).
  • Experimental: Ibrutinib
    Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.

Primary Outcome Measure

Progression Free Survival (PFS) Based on Investigator Assessment [ Time Frame: Median overall follow-up of 82.7 months ]

Locations (16)

FacilityCityStateZIPSite coordinators
City of Hope /ID# 1116-0047DuarteCalifornia91010-
Moores Cancer Center at UC San Diego /ID# 1116-0408La JollaCalifornia92093-
Stanford University/Stanford Cancer Center, Campus Drive /ID# 1116-0038StanfordCalifornia94305-
University of Chicago /ID# 1116-0126ChicagoIllinois60637-
Norton Cancer Institute - St Matthews /ID# 1116-0071LouisvilleKentucky40207-
Comprehensive Cancer Centers of Nevada /ID# 1116-0712HendersonLouisiana89052-
University of Massachusetts - Worcester /ID# 1116-0307WorcesterMassachusetts01655-
Washington University-School of Medicine /ID# 1116-0221St LouisMissouri63110-
Northwell Health/Long Island Jewish Hospital /ID# 1116-0350New Hyde ParkNew York11042-
University of Rochester Medical Center /ID# 1116-0127RochesterNew York14642-0001-
Southeastern Medical Oncology Center /ID# 1116-0656GoldsboroNorth Carolina27534-
Kaiser Permanente - Northwest /ID# 1116-0677PortlandOregon97227-
University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1116-0050PittsburghPennsylvania15232-
University of Texas MD Anderson Cancer Center /ID# 1116-0032HoustonTexas77030-
Oncology of San Antonio /ID# 1116-0653San AntonioTexas78240-
Providence St. Mary Regional Cancer Center /ID# 1116-0731Walla WallaWashington99362-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAMoores Cancer Center at UC San Diego· La Jolla, CAStanford University/Stanford Cancer Center, Campus Drive· Stanford, CAUniversity of Chicago· Chicago, ILNorton Cancer Institute - St Matthews· Louisville, KYComprehensive Cancer Centers of Nevada· Henderson, LA

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