A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma
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ClinicalTrials.gov Identifier: NCT01779791 |
Recruitment Status
:
Completed
First Posted
: January 30, 2013
Last Update Posted
: July 18, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Drug: PCI-32765 (Ibrutinib) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Multicenter, Single-Arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma |
Actual Study Start Date : | April 17, 2013 |
Actual Primary Completion Date : | May 18, 2016 |
Actual Study Completion Date : | May 18, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: PCI-32765 (Ibrutinib) |
Drug: PCI-32765 (Ibrutinib)
560 mg capsules administered orally once daily, continuously on a 21-day cycle until progressive disease.
Other Name: IMBRUVICA
|
- Overall response rate [ Time Frame: Up to 2 years after the last patient is enrolled ]
- Duration of response [ Time Frame: Every 12 weeks during the first 96 weeks, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled) ]
- Progression-free survival [ Time Frame: Up to progressive disease, death, lost to follow-up, withdrawal of consent, or study end (up to 2 years after the last patient is enrolled) ]
- Overall survival [ Time Frame: Up to death, lost to follow-up, withdrawal of consent, or study end (up to 2 years after the last patient is enrolled) ]
- Time to response [ Time Frame: Every 12 weeks during the first 96 weeks, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled) ]
- Number of patients experiencing resolution of lymphoma-related B symptoms [ Time Frame: Day 1 of every cycle during the first 12 months, thereafter every other cycle (up to 2 years after the last patient is enrolled) ]
- Number of patients identified with blood biomarkers that alter B-cell receptor signaling or activate alternative signaling pathways [ Time Frame: Day 1 of Cycles 1-3, and time of disease progression, or at end-of treatment visit for patients who discontinue treatment without disease progression ]
- Minimum plasma concentration of PCI-32765 [ Time Frame: Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours ]
- Oral plasma clearance of PCI-32765 [ Time Frame: Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours ]
- Oral volume of distribution at steady state of PCI-32765 [ Time Frame: Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours ]
- Area under the plasma-concentration time curve of PCI-32765 [ Time Frame: Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours ]
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologic proof of Grade 1, 2, or 3a follicular lymphoma (FL) without clinical or pathological evidence of transformation
- Previously treated with at least 2 prior lines of therapy, including at least 1 rituximab combination chemotherapy regimen; last prior line of therapy includes an anti CD20 monoclonal antibody-containing chemotherapy regimen (separate lines of therapy are defined as different regimens that are either separated by disease progression, refractory disease, or relapsed disease)
- Resistant disease to the last therapy, defined as progression of disease during or within 12 months of the last dose of chemotherapy in a CD20 antibody combination chemotherapy regimen
- At least 1 measurable site of disease according to International Working Group Revised Response Criteria for Malignant Lymphoma
- Eastern Cooperative Oncology Group performance status grade 0 or 1
- Hematology and biochemical laboratory values must be within protocol-defined parameters within 7 days prior to enrollment
- Agrees to protocol-defined use of effective contraception
- Women of childbearing potential must have a negative serum or urine pregnancy test at screening
Exclusion Criteria:
- Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug
- Prior treatment with PCI-32765 or other Bruton's tyrosine kinase inhibitors (patients who progressed or became refractory while on treatment with PI3K inhibitors are excluded)
- Concurrent enrollment in another therapeutic investigational clinical treatment study
- Received a prior allogeneic hematopoietic stem cell transplant (prior autologous hematopoietic stem cell transplant is allowed)
- Known central nervous system lymphoma
- History of prior malignancy (except malignancy treated with curative intent and with no known active disease present for >=3 years before enrollment, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, or adequately treated cervical carcinoma in situ without evidence of disease)
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists
- Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
- Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C or active infection with Hepatitis B or any uncontrolled active systemic infection requiring intravenous antibiotics
- Women who are pregnant or breastfeeding
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of PCI-32765 capsules, or put the study outcomes at undue risk

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779791

Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Additional Information:
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT01779791 History of Changes |
Other Study ID Numbers: |
CR100956 2012-004097-26 ( EudraCT Number ) PCI-32765FLR2002 ( Other Identifier: Janssen Research & Development, LLC ) |
First Posted: | January 30, 2013 Key Record Dates |
Last Update Posted: | July 18, 2017 |
Last Verified: | July 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Janssen Research & Development, LLC:
Lymphoma Refractory follicular lymphoma Chemoimmunotherapy-resistant follicular lymphoma |
PCI-32765 Ibrutinib IMBRUVICA |
Additional relevant MeSH terms:
Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |