Open-label, Phase II Study of MLN9708 in Patients With Relapsed/Refractory Cutaneous and Peripheral T-cell Lymphomas
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|ClinicalTrials.gov Identifier: NCT02158975|
Recruitment Status : Completed
First Posted : June 9, 2014
Results First Posted : November 13, 2017
Last Update Posted : November 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, T-Cell||Drug: MLN9708||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Single-center Phase II Study of MLN9708 (Ixazomib) in Patients With Relapsed/Refractory Cutaneous and Peripheral T-cell Lymphomas|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||November 2016|
MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.
- Objective Response Rate [ Time Frame: Up to 24 months after initiation of study treatment ]The percentage of patients with an objective response rate will be determined. The overall response will be based on response in each compartment (skin, blood, lymph nodes and viscera) using a global composite scoring system. Objective response is considered (CR) Complete Response (Complete disappearance of all clinical evidence of disease), CRu (Complete Response Unconfirmed), or (PR) Partial Response (Regression of measurable disease).
- Number Patients That Experience 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 number of patients experiencing Adverse Events (AEs) greater than or equal to grade 3 will be recorded.
- Median Progression Free Survival Time [ Time Frame: 24 months after initiation of study treatment ]Progression Free Survival (PFS) is defined as the time from study start until disease progression or death.
- Median Overall Survival Time [ Time Frame: 24 months after initiation of study treatment ]Overall Survival (OS) is defined as the 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.
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): 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|