A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

October 28, 2013

Primary Completion Date

December 1, 2015

Study Completion Date

August 11, 2017

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Rituximab

Up to 6 cycles (total of 8 doses administered by intravenous infusion): 375 mg/m2 on Day 1 of Cycle 1, 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); and 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24).

DRUG

Ibrutinib

420 mg capsules administered by mouth daily until disease progression or unacceptable toxicity, whichever occurs first.

Trial Locations (26)

Unknown

Concord

Gosford

Heidelberg

Perth

Tweed Heads

Beijing

Chendu

Fuzhou

Guangzhou

Jinan

Nanjing

Qingdao

Shanghai

Suzhou

Tianjin

Unk Hangzhou

Wuhan

Xi'an

Johor Bahru

Kuala Lumpur

Malacca

Subang Jaya

Changhua

Kaohsiung City

Tainan City

Taipei

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY

NCT01973387 - A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma | Biotech Hunter | Biotech Hunter