A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Part of paid clinical trials in La Jolla, California.

Sponsor
Pharmacyclics LLC.
Study ID
NCT01578707
Phase
PHASE3
Status
Completed

Conditions

  • Relapsed or Refractory Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Eligibility Criteria

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

Interventions

  • ofatumumab — DRUG
    The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
  • ibrutinib — DRUG
    ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Study Details

The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Key Dates

Start date
Jun 30, 2012
Status verified
Dec 2019
Primary completion
Nov 30, 2013
Completion
Oct 25, 2018

Study Design

Enrollment
391 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ofatumumab (Arm A)
    An anti-CD20 monoclonal antibody
  • Experimental: ibrutinib (Arm B)
    A Bruton Tyrosine Kinase Inhibitor

Primary Outcome Measure

PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013 [ Time Frame: Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled. ]

Locations (25)

FacilityCityStateZIPSite coordinators
Site #408La JollaCalifornia92093-0698-
Site #377Los AngelesCalifornia90095-
Site #403Santa MariaCalifornia93454-
Site #038StanfordCalifornia94035-
Site #411NorwalkConnecticut06856-
Site #107MariettaGeorgia30060-
Site # 379EvansvilleIndiana47713-
Site # 349BostonMassachusetts02215-
Site # 390BostonMassachusetts02114-
Site # 391BostonMassachusetts02115-
Site # 130DetroitMichigan48201-
Site # 406RochesterMinnesota55901-
Site # 059New BrunswickNew Jersey08903-
Site # 350New Hyde ParkNew York11042-
Site # 200New YorkNew York10065-
Site # 127RochesterNew York14642-0001-
Site # 197CincinnatiOhio45291-
Site # 217ColumbusOhio43210-
Site # 402PhiladelphiaPennsylvania19104-
Site # 396GreenvilleSouth Carolina29601-
Site # 410NashvilleTennessee37232-5505-
Site # 032HoustonTexas77030-
Site # 381LaredoTexas78041-
Site # 210CharlottesvilleVirginia22908-
Site # 404SeattleWashington98109-

Find similar trials in La Jolla, CA

By research site
Site #408· La Jolla, CASite #377· Los Angeles, CASite #403· Santa Maria, CASite #038· Stanford, CASite #411· Norwalk, CTSite #107· Marietta, GA

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