Title: A Phase 2 Study of Ixazomib and Rituximab in Bruton Tyrosine Kinase Inhibitor Resistant Mantle Cell Lymphoma
Principal Investigator: Hun J Lee, MD, MD Anderson Cancer Center, Houston, Texas
Description: This phase 2 trial is studying how well ixazomib and rituximab work in combination to treat patients with relapsed/refractory mantle cell after Bruton tyrosine kinase (BTK) inhibitor treatment. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with rituximab may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. The researchers hypothesize that giving ixazomib and rituximab together may work better in treating patients with mantle cell lymphoma compared with giving rituximab alone. The primary objective of this trial is to evaluate the complete remission rate of BTK inhibitor refractory mantle cell lymphoma patients with ixazomib and rituximab at 16 weeks of therapy. A secondary objective is to evaluate the overall response rate assessed by Lugano criteria and to evaluate progression free survival and overall survival. In addition, the researchers are seeking to evaluate the safety and tolerability of the combination of ixazomib and rituximab.
Status: This study is open and recruiting patients as of August 28, 2019.
This study is sponsored by MD Anderson Cancer Center in collaboration with the National Cancer Institute.
Clinicaltrials.gov. Ixazomib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma. NCT04047797. https://clinicaltrials.gov/ct2/show/NCT04047797. Accessed December 10, 2019.