A Phase II Study of Pembrolizumab Immunotherapy, Ublituximab, and Umbralisib Given Together in Patients with Chronic Lymphocytic Leukemia

Full Title

Phase I/II Study of Pembrolizumab in Combination with TG-1101 (ublituximab) and TGR-1202 (umbralisib) in Patients with Relapsed-Refractory CLL or Richter’s Transformation of CLL

Purpose

Chronic lymphocytic leukemia (CLL) is a disease that typically responds to treatment but can come back repeatedly, requiring additional regimens of therapy over many years. Richter’s lymphoma is a rare complication of CLL. In this study, researchers are evaluating the safety and effectiveness of a trio of medications to use in patients with CLL and Richter’s transformation of CLL that has come back or continued to grow despite initial therapy. The three drugs are pembrolizumab, ublituximab, and umbralisib.

Pembrolizumab is an immunotherapy drug which blocks PD-1, a protein cancer cells use to evade detection by the immune system, thereby enabling the immune system to find and kill cancer cells. It is used to treat several types of cancer; its use in this study is considered investigational.

Ublituximab is an antibody that targets and attaches to the CD20 protein on CLL cells and some healthy blood cells. It may help the immune system destroy CLL cells as well as kill cancer cells directly. Umbralisib works by blocking a protein in the blood called PI3K. In many B-cell cancers, including CLL, this protein triggers cancer cells to develop and helps them survive. Blocking PI3K may slow the spread of CLL.

Pembrolizumab and ublituximab are given intravenously (by vein), and umbralisib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have B-cell CLL that has continued to grow despite treatment that included at least two cycles of ibrutinib or acalabrutinib and continued to grow while on or within 6 months of finishing this therapy, OR patients must have Richter’s transformation of CLL that continued to grow despite standard chemoimmunotherapy.
  • At least 2 weeks must pass between the completion of prior therapies and entry into the study (1 week since kinase inhibitor therapy or venetoclax).
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Anthony Mato at 212-639-8596.

Protocol

18-283

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators