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

PHASE3CompletedINTERVENTIONAL
Enrollment

391

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

November 30, 2013

Study Completion Date

October 25, 2018

Conditions
Relapsed or Refractory Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

ofatumumab

"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)"

DRUG

ibrutinib

ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Trial Locations (76)

8

Site # 570, Dublin

9

Site # 528, Dublin

1160

Site # 506, Wein

2060

Site # 393, Antwerp

2065

Site # 500, St Leonards

3002

Site # 199, East Melbourne

3109

Site # 501, Fitzroy

4010

Site # 508, Linz

4102

Site # 503, Brisbane

5020

Site # 504, Salzburg

6009

Site # 502, Nedlands

8036

Site # 509, Graz

10065

Site # 200, New York

11042

Site # 350, New Hyde Park

13273

Site # 510, Marseille

14033

Site # 516, Caen

19104

Site # 402, Philadelphia

20089

Site # 522, Milan

20132

Site # 523, Milan

20162

Site # 526, Milan

22908

Site # 210, Charlottesville

28033

Site # 540, Madrid

28050

Site # 537, Madrid

28222

Site # 536, Madrid

29601

Site # 396, Greenville

30060

Site #107, Marietta

31008

Site # 538, Pamplona

33076

Site # 515, Bordeaux

35033

Site # 518, Rennes

35128

Site # 527, Padua

41124

Site # 524, Modena

43210

Site # 217, Columbus

44000

Site # 520, Nantes

45291

Site # 197, Cincinnati

47713

Site # 379, Evansville

48201

Site # 130, Detroit

54511

Site # 517, Vandœuvre-lès-Nancy

55901

Site # 406, Rochester

63100

Site # 513, Clermont-Ferrand

77030

Site # 032, Houston

78041

Site # 381, Laredo

90095

Site #377, Los Angeles

93009

Site # 511, Bobigny

93454

Site #403, Santa Maria

94035

Site #038, Stanford

95107

Site # 519, Argenteuil

98109

Site # 404, Seattle

92093-0698

Site #408, La Jolla

06856

Site #411, Norwalk

02114

Site # 390, Boston

02115

Site # 391, Boston

02215

Site # 349, Boston

08903

Site # 059, New Brunswick

14642-0001

Site # 127, Rochester

37232-5505

Site # 410, Nashville

A-1090

Site # 505, Vienna

A-4600

Site # 507, Wels

Unknown

Site # 096, Galway

80-952

Site # 529, Gdansk

93-510

Site # 531, Lodz

15006A

Site # 539, A Coruña

08025

Site # 535, Barcelona

08035

Site # 534, Barcelona

08036

Site # 533, Barcelona

CO4 5JL

Site # 549, Colchester

SM2 5PT

Site # 543, Sutton

BH7 7DW

Site # 551, Bournemouth

CT1 3NG

Site # 553, Canterbury

CF14 4XW

Site # 546, Cardiff

OX3 7LJ

Site # 554, Headington

LS9 7TF

Site # 550, Leeds

L7 8XP

Site # 552, Liverpool

SE5 9RS

Site # 544, London

NG5 1PB

Site # 548, Nottingham

SO16 6YD

Site # 545, Southampton

M20 4BX

Site # 541, Withington

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Pharmacyclics LLC.

INDUSTRY

NCT01578707 - A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia | Biotech Hunter | Biotech Hunter