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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01973387 |
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Date of registration:
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25/10/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma
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Scientific title:
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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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Date of first enrolment:
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October 28, 2013 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01973387 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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China
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Malaysia
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Taiwan
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Contacts
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Name:
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Janssen Research & Development, LLC Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Research & Development, LLC |
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Key inclusion & exclusion criteria
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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
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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Lymphocytic Leukemia
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Small Lymphocytic Lymphoma
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Intervention(s)
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Drug: Ibrutinib
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Drug: Rituximab
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Primary Outcome(s)
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Progression-free Survival (PFS)
[Time Frame: 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(s)
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Overall Survival (OS)
[Time Frame: From the date of randomization to the date of death (Up to 3.7 years)]
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Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms
[Time Frame: From the date of randomization to disease progression (Up to 3.7 years)]
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Number of Participants With Sustained Hematologic Improvement
[Time Frame: From the date of randomization to disease progression (Up to 3.7 years)]
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Overall Response Rate (ORR)
[Time Frame: From the date of randomization to disease progression (Up to 3.7 years)]
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Secondary ID(s)
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PCI-32765CLL3002
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CR102604
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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