Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma
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ClinicalTrials.gov Identifier: NCT02169180 |
Recruitment Status :
Completed
First Posted : June 23, 2014
Last Update Posted : January 24, 2017
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Condition or disease | Intervention/treatment | Phase |
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Lymphoma, Mantle-cell | Drug: Ibrutinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL) |
Study Start Date : | August 2014 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | December 2016 |
Arm | Intervention/treatment |
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Experimental: Ibrutinib
Participants will receive ibrutinib capsules 560 milligram (mg) orally, once daily on a 28-day cycle up to 7 cycles or until disease progression (or relapse if the participant achieved a complete response [CR]), unacceptable toxicity, or end of treatment, whichever occurs first.
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Drug: Ibrutinib
Participants will receive ibrutinib capsules 560 milligram (mg) orally, once daily on a 28-day cycle up to 7 cycles or until disease progression (or relapse if the participant achieved a complete response [CR]), unacceptable toxicity, or end of treatment, whichever occurs first.
Other Names:
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- Percentage of Participants With Overall Response [ Time Frame: Up to 2 years after last participant enrolled ]Overall response is defined as achievement of complete response (CR) or partial response (PR), as assessed by the Independent Review Committee (IRC), based on the Revised Response Criteria for Malignant Lymphoma. CR is: a) disappearance of all detectable disease symptoms and signs; b) lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size; c) negative positron emission tomography (PET) scan; d) normal sized spleen or liver if enlarged before therapy; d) bone marrow infiltrate must be cleared if would have been involved before treatment; e) no new sites of disease. PR is: a) greater than 50 percent decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, splenic and hepatic nodules; b) no increase in the size of other nodes, liver, or spleen, c) no measurable disease in other organs; d) no new sites of disease; e) 1 PET-positive site of disease (required for the CT+PET assessment of PR).
- Duration of Response [ Time Frame: Up to 2 years after last participant enrolled ]Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
- Time to Response [ Time Frame: Up to 2 years after last participant enrolled ]Time to response is the time from the date of first dose of study drug until the first date of initial documentation of a response (CR or PR).
- Overall Survival (OS) [ Time Frame: Up to 2 years after last participant enrolled ]The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
- Progression-free Survival (PFS) [ Time Frame: Up to 2 years after last participant enrolled ]The PFS is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
- Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 up to 30 days after last dose administration ]An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.
- Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]) [ Time Frame: Predose (0), 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and 2 ]The AUC (0-last) is the area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
- Apparent Clearance (CL/F) [ Time Frame: Predose (0), 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and 2 ]The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration.
- Minimum Observed Plasma Concentration (Cmin) [ Time Frame: Predose (0) and 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and Cycle 2 ]Minimum Observed Plasma Concentration (Cmin) will be observed.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of mantle cell lymphoma ( MCL) must include morphology and expression of either cyclin D1 in association with one B-cell marker (for example, cluster of differentiation [CD] CD19, CD20, or paired box [PAX5]) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)
- Received at least 1 prior lines of therapy for MCL (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6-month treatment-free interval)
- At least 1 measurable site of disease according to the Revised Response Criteria for Malignant Lymphoma (that is, the site of disease must be greater than 1.5 centimeter [cm] in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions)
- Have documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent anti-MCL treatment regimen
- Eastern Cooperative Oncology Group performance status score of 0 or 1
Exclusion Criteria:
- Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 4 weeks of the first dose of study drug
- Prior treatment with ibrutinib or other Bruton's Tyrosine Kinase (BTK) inhibitors
- More than 5 prior lines of therapy for MCL (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6-month treatment-free interval)
- Known central nervous system (CNS) lymphoma
- Woman who is pregnant, breast-feeding, or planning to become pregnant within 1 month after the last dose of study drug or is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
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): NCT02169180
Japan | |
Fukuoka, Japan | |
Isehara, Japan | |
Kobe, Japan | |
Kyoto, Japan | |
Nagoya, Japan | |
Osaka, Japan | |
Sendai, Japan | |
Tokyo, Japan |
Study Director: | Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. |
Responsible Party: | Janssen Pharmaceutical K.K. |
ClinicalTrials.gov Identifier: | NCT02169180 |
Other Study ID Numbers: |
CR104615 PCI-32765MCL2002 ( Other Identifier: Janssen Pharmaceutical K.K., Japan ) |
First Posted: | June 23, 2014 Key Record Dates |
Last Update Posted: | January 24, 2017 |
Last Verified: | January 2017 |
Ibrutinib IMBRUVICA PCI-32765 JNJ-54179060 Lymphoma, Mantle-cell |
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, Non-Hodgkin Ibrutinib Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |