- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01569750
A Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With CD20-Positive B-Cell Non Hodgkin Lymphoma
A Phase 1b Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With CD20-Positive B-Cell Non Hodgkin Lymphoma (NHL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Lille Cedex, France
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Paris, France
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Vandoeuvre Les Nancy, France
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New York
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New York, New York, United States
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Rochester, New York, United States
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Tennessee
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Nashville, Tennessee, United States
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Texas
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Houston, Texas, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histopathologically-confirmed CD20-positive B-cell non Hodgkin lymphoma disease for whom R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) is an appropriate therapy (diffuse large B-cell lymphoma, mantle cell lymphoma, or follicular lymphoma); for the expansion cohort, at least 1 cohort will only include patients with newly diagnosed diffuse large B-cell lymphoma
- Stage I AX (bulk defined as single lymph node mass >=10 cm in diameter) to Stage IV disease
- At least 1 measurable site of disease based on the Revised Response Criteria for Malignant Lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Adequate bone marrow, liver, and renal function
Exclusion Criteria:
- History of protocol-defined disallowed therapies
- Prior multidrug chemotherapy treatment for lymphoma
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug
- Major surgery within 3 weeks before enrollment
- Known bleeding diatheses, platelet dysfunction disorders, or requires therapeutic anticoagulation
- Known lymphoma of the central nervous system
- Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, pericardial disease, cardiac amyloidosis, clinically significant cardiac arrhythmia, or left ventricular ejection fraction outside of institutional limits
- Active systemic infection requiring treatment including hepatitis B and hepatitis C infection
- Documented or suspected human immunodeficiency virus infection
- Diagnosed or treated for a malignancy other than non-Hodgkin lymphoma except; adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ of the breast, or other solid tumors curatively treated with no evidence of disease for >5 years
- Has any condition that, in the opinion of the investigator, would make study participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ibrutinib
Part 1 (Dose Escalation): Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) until maximum tolerated dose is achieved. Part 2: Ibrutinib at the recommended Part 1 dose administered once daily with standard-of-care doses of R-CHOP. |
Type=exact number, unit=mg, number=280, form=capsule, route=oral use.
Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.
Type=exact number, unit=mg, number=420, form=capsule, route=oral use.
Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.
Type=exact number, unit=mg, number=560, form=capsule, route=oral use.
Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.
Ibrutinib at the recommended Part 1 dose administered once daily with standard-of-care doses of R-CHOP in patients with newly diagnosed diffuse large B-cell lymphoma.
Ibrutinib at the recommended Part 1 dose administered once daily with standard-of-care doses of R-CHOP in patients with newly diagnosed with B-cell non-Hodgkin lymphoma.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Part 1 maximum tolerated dose of ibrutinib
Time Frame: Up to Cycle 1, Day 21 in Part 1
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The Part 1 maximum tolerated dose (MTD) is the Part 2 recommended ibrutinib dose.
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Up to Cycle 1, Day 21 in Part 1
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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The number of participants affected by an adverse event
Time Frame: Up to 30 days after the last dose of study medication
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Up to 30 days after the last dose of study medication
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The number of participants affected by a dose-limiting toxicity
Time Frame: Up to Cycle 6, Day 21 in Part 1
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Up to Cycle 6, Day 21 in Part 1
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Number of participants with potential drug-drug interactions between ibrutinib and vincristine
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Overall response rate
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Duration of response
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Progression-free survival
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Mean plasma concentrations of ibrutinib
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Maximum observed plasma concentration of ibrutinib
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Time to reach the maximum plasma concentration of ibrutinib
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Area under the plasma concentration-time curve from time 0 to 24 hours of ibrutinib
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of ibrutinib
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of vincristine
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Partial area under the plasma concentration versus time curve of vincristine
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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The number of participants with pharmacodynamic markers of ibrutinib in peripheral blood mononuclear cells
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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The number of participants with biomarkers predictive of clinical response
Time Frame: Up to Cycle 6, Day 21 in Part 2
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Up to Cycle 6, Day 21 in Part 2
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100844
- PCI-32765DBL1002 (Other Identifier: Janssen Research & Development, LLC)
- 2012-000546-35 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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