Open-label, Phase II Study of MLN9708 in Patients With Relapsed/Refractory Cutaneous and Peripheral T-cell Lymphomas
Historically cutaneous and peripheral T-cell lymphomas have response rates of approximately 30% to standard chemotherapy regimens. We alternatively hypothesize that MLN9708 will be active in this disease and will improve best objective response.
We will also determine the extent to which MLN9708 inhibits GATA-3 (Trans-acting T-cell-specific transcription factor) expression, which is associated with poor prognosis, and whether GATA-3 expression represents a novel predictive biomarker for MLN9708 sensitivity.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-label, Single-center Phase II Study of MLN9708 (Ixazomib) in Patients With Relapsed/Refractory Cutaneous and Peripheral T-cell Lymphomas|
- Objective Response Rate [ Time Frame: 24 months after initiation of study treatment ]Objective response is considered CR (Complete Response), CRu (Complete Response Unknown), or PR (Partial Response) and will be measured after every 2nd cycle of treatment until the 6th cycle, then every 3 months until 24 months, then every 6 months, all until disease progression or death. All patients receiving any MLN9708 therapy per protocol are considered evaluable for the primary endpoint; however, patients not able to receive at least 2-cycles of MLN9708 with an accompanying response assessment will be considered treatment failures.
- Number of Adverse Events, Grades 3-5 [ Time Frame: 30 days after the last dose of study drug ]To assess the safety and tolerability of MLN9708, the incidence of Adverse Events (AEs), as well as severity, seriousness and relatedness will be recorded.
- Progression Free Survival Time [ Time Frame: 24 months after initiation of study treatment ]Time from study start until disease progression or death.
- Overall Survival Time [ Time Frame: 24 months after initiation of study treatment ]Time from study start until death.
- Duration of Response [ Time Frame: 24 months after initiation of study treatment ]Time from documentation of tumor response to disease progression.
|Study Start Date:||September 2014|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02158975
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Ryan Wilcox, M.D., Ph.D.||University of Michigan Cancer Center|