Alisertib, Romidepsin, Relapsed, Clinical Trials

Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas

This study is completed.

This phase I trial studies the side effects and best dose of alisertib and romidepsin in treating patients with B-cell or T-cell lymphomas that have returned after a period of improvement (relapsed) or have not responded to treatment (refractory). Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving alisertib and romidepsin may be a better treatment for relapsed or refractory B-cell or T-cell lymphomas.

Study Type:  Interventional

Study Design:  

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Official Title:  A Phase 1 Trial of MLN8237 Plus Romidepsin for Relapsed/Refractory Aggressive B-Cell and T-Cell Lymphomas

Conditions:  

Recurrent B-Cell Non-Hodgkin Lymphoma
Recurrent Burkitt Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Follicular Lymphoma
Recurrent Hodgkin Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma
Refractory Burkitt Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory Follicular Lymphoma
Refractory Hodgkin Lymphoma
Refractory Mantle Cell Lymphoma
Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Interventions:  

Drug: Alisertib
Other: Laboratory Biomarker Analysis
Drug: Romidepsin

Phase:  Phase 1

External Link:  https://clinicaltrials.gov/ct2/show/NCT01897012