A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma
A Randomized, Multicenter, Open-Label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor PCI-32765 (Ibrutinib) Versus Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
2 other identifiers
interventional
160
4 countries
26
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus rituximab in adult Asia Pacific region patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2013
Typical duration for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2013
CompletedStudy Start
First participant enrolled
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
October 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedResults Posted
Study results publicly available
February 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2017
CompletedJuly 24, 2018
June 1, 2018
2.1 years
October 25, 2013
November 29, 2016
June 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
Progression-free survival was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for progressive disease (PD): New enlarged nodes greater than (\>)1.5 centimeter (cm), new hepatomegaly or splenomegaly, or other organ infiltrates; greater than or equal to (\>=)50 percent (%) increase from nadir in existing lymph node or \>=50% increase from nadir in sum of product of diameters of multiple nodes; \>=50% increase from nadir in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) unless considered treatment-related lymphocytosis; New cytopenia (Hemoglobin b \[Hgb\] or platelets) attributable to chronic lymphocytic leukemia (CLL) and transformation to a more aggressive histology.
From the date of randomization to the date of disease progression or death, whichever was first reported (Up to 3.7 years)
Secondary Outcomes (4)
Overall Response Rate (ORR)
From the date of randomization to disease progression (Up to 3.7 years)
Overall Survival (OS)
From the date of randomization to the date of death (Up to 3.7 years)
Number of Participants With Sustained Hematologic Improvement
From the date of randomization to disease progression (Up to 3.7 years)
Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms
From the date of randomization to disease progression (Up to 3.7 years)
Study Arms (2)
Treatment Arm A
EXPERIMENTALTreatment Arm B
EXPERIMENTALInterventions
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).
420 mg capsules administered by mouth daily until disease progression or unacceptable toxicity, whichever occurs first.
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group performance status of 0-1
- Diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that meets protocol-defined criteria
- Laboratory values within protocol-defined parameters
- Active disease meeting International Workshop on Chronic Lymphocytic Leukemia 2008 criteria
- Received at least 1 prior therapy for CLL/SLL and not appropriate for treatment or retreatment with purine analog-based therapy
- Measurable nodal disease by computed tomography
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test at Screening and agree to use highly effective methods of contraception during the study and for 90 days following the last dose with ibrutinib or 12 months following the last dose of rituximab
You may not qualify if:
- Central nervous system lymphoma or leukemia
- Prolymphocytic leukemia or history of or currently suspected Richter's transformation
- Refractory to prior rituximab-based therapy
- Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days prior to first dose of study drug
- Corticosteroid use \>20 mg within 1 week prior to first dose of study drug
- Radio- or toxin-conjugated antibody therapy within 10 weeks prior to first dose of study drug
- Prior autologous transplant within 6 months prior to first dose of study drug
- Prior allogeneic stem cell transplant
- Major surgery within 4 weeks prior to first dose of study drug
- History of prior malignancy according to protocol-defined criteria
- Currently active clinically significant cardiovascular disease within 6 months prior to first dose with study drug
- Uncontrolled active systemic fungal, bacterial, viral, or other ongoing anti-infective treatment administered intravenously
- History of human immunodeficiency virus or active infection with hepatitis B or C
- History of stroke or intracranial hemorrhage within 6 months prior to random assignment
- Pregnant or lactating women
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Pharmacyclics LLC.collaborator
Study Sites (26)
Unknown Facility
Concord, Australia
Unknown Facility
Gosford, Australia
Unknown Facility
Heidelberg, Australia
Unknown Facility
Perth, Australia
Unknown Facility
Tweed Heads, Australia
Unknown Facility
Beijing, China
Unknown Facility
Chendu, China
Unknown Facility
Fuzhou, China
Unknown Facility
Guangzhou, China
Unknown Facility
Jinan, China
Unknown Facility
Nanjing, China
Unknown Facility
Qingdao, China
Unknown Facility
Shanghai, China
Unknown Facility
Suzhou, China
Unknown Facility
Tianjin, China
Unknown Facility
Unk Hangzhou, China
Unknown Facility
Wuhan, China
Unknown Facility
Xi'an, China
Unknown Facility
Johor Bahru, Malaysia
Unknown Facility
Kuala Lumpur, Malaysia
Unknown Facility
Malacca, Malaysia
Unknown Facility
Subang Jaya, Malaysia
Unknown Facility
Changhua, Taiwan
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President (VP)
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2013
First Posted
October 31, 2013
Study Start
October 28, 2013
Primary Completion
December 1, 2015
Study Completion
August 11, 2017
Last Updated
July 24, 2018
Results First Posted
February 23, 2017
Record last verified: 2018-06