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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01973387
Registration number
NCT01973387
Ethics application status
Date submitted
25/10/2013
Date registered
31/10/2013
Date last updated
24/07/2018
Titles & IDs
Public title
A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma
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Scientific title
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
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Secondary ID [1]
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PCI-32765CLL3002
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Secondary ID [2]
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CR102604
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia
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Small Lymphocytic Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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0
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rituximab
Treatment: Drugs - Ibrutinib
Experimental: Treatment Arm A -
Experimental: Treatment Arm B -
Treatment: Drugs: 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).
Treatment: Drugs: Ibrutinib
420 mg capsules administered by mouth daily until disease progression or unacceptable toxicity, whichever occurs first.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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From the date of randomization to the date of disease progression or death, whichever was first reported (Up to 3.7 years)
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL) and absolute lymphocyte count <4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR- >=50% drop in lymphocyte count from baseline or <=4.0*10^9/L with following: >=50% decrease in sum products of up to 6 lymph nodes, no new enlarged lymph nodes, When abnormal, >=50% decrease in enlargement of spleen from baseline or normalization and a response in 1 of following: Neutrophils >1.5*10^9/L, Platelets>100000/mcL and Hgb>11 g/dL or >=50% improvement over baseline in all.
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Timepoint [1]
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From the date of randomization to disease progression (Up to 3.7 years)
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall survival was defined as the interval between the date of randomization and the date of death from any cause.
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Timepoint [2]
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From the date of randomization to the date of death (Up to 3.7 years)
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Secondary outcome [3]
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Number of Participants With Sustained Hematologic Improvement
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Assessment method [3]
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Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (>)100* 109/liter (L) if baseline less than or equal to (<=) 100*109/L or increase >= 50 percent (%) over baseline; 2) Hemoglobin >11 gram per deciliters (g/dL) if baseline <= 11 g/dL or increase >= 2 g/dL over baseline.
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Timepoint [3]
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From the date of randomization to disease progression (Up to 3.7 years)
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Secondary outcome [4]
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Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms
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Assessment method [4]
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The most common disease-related symptoms associated with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) (fatigue, weight loss, fevers, night sweats, and abdominal discomfort/splenomegaly) were reported by grade.
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Timepoint [4]
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From the date of randomization to disease progression (Up to 3.7 years)
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Eligibility
Key inclusion criteria
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
- Current life-threatening illness, medical condition, or organ system dysfunction
which, in the investigator's opinion, could compromise the patient's safety, or put
the study at risk
- Requires or receiving anticoagulation with warfarin or equivalent Vitamin K
antagonists
- Requires treatment with a strong CYP3A4/5 inhibitor
- Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura
(ITP), defined as declining hemoglobin or platelet count secondary to autoimmune
destruction within the screening period or requirement for high doses of steroids
(greater than [>]20 milligram [mg] daily of prednisone daily or equivalent)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/08/2017
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Sample size
Target
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Concord
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Recruitment hospital [2]
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- Gosford
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Recruitment hospital [3]
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- Heidelberg
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Recruitment hospital [4]
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- Perth
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Recruitment hospital [5]
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- Tweed Heads
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Recruitment postcode(s) [1]
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- Concord
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Recruitment postcode(s) [2]
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- Gosford
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Recruitment postcode(s) [3]
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- Heidelberg
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Recruitment postcode(s) [4]
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- Perth
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Recruitment postcode(s) [5]
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- Tweed Heads
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Beijing
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Country [2]
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China
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State/province [2]
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Chendu
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Country [3]
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China
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State/province [3]
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Fuzhou
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Country [4]
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China
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State/province [4]
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Guangzhou
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Country [5]
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China
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State/province [5]
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Jinan
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Country [6]
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China
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State/province [6]
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Nanjing
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Country [7]
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China
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State/province [7]
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Qingdao
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Country [8]
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China
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State/province [8]
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Shanghai
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Country [9]
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China
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State/province [9]
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Suzhou
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Country [10]
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China
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State/province [10]
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Tianjin
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Country [11]
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China
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State/province [11]
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Unk Hangzhou
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Country [12]
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China
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State/province [12]
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Wuhan
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Country [13]
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China
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State/province [13]
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Xian
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Country [14]
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Malaysia
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State/province [14]
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Johor Bahru
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Country [15]
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Malaysia
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State/province [15]
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Kuala Lumpur
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Country [16]
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Malaysia
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State/province [16]
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Melaka
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Country [17]
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Malaysia
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State/province [17]
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Subang Jaya
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Country [18]
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Taiwan
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State/province [18]
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Changhua
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Country [19]
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Taiwan
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State/province [19]
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Kaohsiung
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Country [20]
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Taiwan
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State/province [20]
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Tainan
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Country [21]
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Taiwan
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State/province [21]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Pharmacyclics LLC.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01973387
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01973387
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