Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL
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|ClinicalTrials.gov Identifier: NCT02419560|
Recruitment Status : Unknown
Verified May 2018 by Craig Portell, MD, University of Virginia.
Recruitment status was: Recruiting
First Posted : April 17, 2015
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Mantle-Cell Recurrent Lymphoma, Mantle-Cell||Drug: ABT-199 and Ibrutinib Combination||Phase 1|
This is a multi-center, study which will be open at up to 4 clinical sites. The purpose of this study is to determine the optimal dosing scheme for the combination of ibrutinib with ABT-199 for the treatment of relapsed or refractory mantle cell lymphoma (MCL). The main criterion for eligibility is MCL with measurable disease which is relapsed or refractory to at least 1 chemotherapy-containing regimen and has not been previously treated with ibrutinib.
This dose finding study will use a continual reassessment method, which accounts for both toxicity and efficacy in combinations of agents, to determine the optimal combination of the approved treatment ibrutinib with the investigational agent ABT-199. This study will accrue patients in two stages. In the initial stage, subjects will be accrued to dosing cohorts of increasing dosages of ABT-199 in combination with ibrutinib. The modeling is initiated once 1 subject experiences a dose limiting toxicity (DLT). During the modeling stage, treatment assignments will be made based on model prediction.
Subjects will remain on treatment until progression or unacceptable toxicity, and will be monitored for safety during the treatment interval. Safety will be evaluated by incidence of adverse events and number of discontinuations due to AEs. Efficacy endpoints include Overall Response Rate (ORR), Complete Response Rate (CRR), minimal residual disease response rate, and survival (PFS and OS). The study will also include exploratory analysis of the gene expression pattern in subjects who progress on treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-institution Phase I/Ib Study of Ibrutinib With ABT-199 in Relapsed/Refractory Mantle Cell Lymphoma|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: ABT-199 and Ibrutinib Combination
Participants will take ABT-199 (dose 100-400 mg) and Ibrutinib (dose 280-560 mg).
Drug: ABT-199 and Ibrutinib Combination
Both are administered orally once daily.
- Incidence of Dose Limiting Toxicities [ Time Frame: 30 Days Following Start of Treatment ]
- Incidence and Severity of Adverse Events [ Time Frame: Through 30 Days Following the Last Treatment ]
- Overall Response Rate [ Time Frame: Every Year Until Death; an Average of 2 Years ]
- Complete Response Rate [ Time Frame: Every Year Until Death; an Average of 2 Years ]
- Progression-Free Survival [ Time Frame: Every Year Until Death; an Average of 2 Years ]
- Overall Survival [ Time Frame: Every Year Until Death; an Average of 2 Years ]
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): NCT02419560
|Contact: Steve Fowler||(434) firstname.lastname@example.org|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Jaemee Bautistia 626-218-3033 email@example.com|
|Principal Investigator: Robert Chen, MD|
|United States, Georgia|
|Winship Cancer Institute, Emory University||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Alicia Escobar 404-778-4449 firstname.lastname@example.org|
|Principal Investigator: Jonathon Cohen, MD|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Christina Lapka 314-747-1798 email@example.com|
|Principal Investigator: Brad Kahl, MD|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Kristen Johnson 434-297-4185 KLJ7U@hscmail.mcc.virginia.edu|
|Contact: Kim Underwood 434-982-3947 firstname.lastname@example.org|
|Principal Investigator: Craig Portell, MD|
|Sub-Investigator: Mike Williams, MD|
|Study Chair:||Craig A Portell, MD||University of Virginia|