A Phase II Study of DTRMWXHS-12, Everolimus, and Pomalidomide in People with Recurrent or Persistent Chronic Lymphocytic Leukemia or Non-Hodgkin Lymphoma

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Full Title

Phase II Expansion Cohorts Studies of a Novel Triple Combination Therapy, DTRM-555, in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Non-Hodgkin’s Lymphomas

Purpose

The purpose of this study is to assess the safety and effectiveness of a triple-drug combination in patients with chronic lymphocytic leukemia (CLL) or non-Hodgkin lymphoma (NHL) that has come back or continued to grow despite prior treatment. The three drugs, DTRMWXHS-12, everolimus, and pomalidomide, have been shown to slow or stop tumor growth in patients in earlier studies, including some tumors that disappeared completely.

DTRMWXHS-12 works by blocking the actions of a protein in some leukemia and lymphoma cells called BTK. Blocking BTK can kill these cells or stop them from making more cancer cells. Everolimus works by blocking a cell signaling pathway called mTOR, which cancer cells use to grow and survive. Pomalidomide is similar to the drug thalidomide, and can help certain cells used by the immune system fight cancer while also stopping cell growth by limiting the blood supply to cancer cells. These medications are taken orally (by mouth) in combination tablets.

Eligibility

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

  • Patients must have CLL, diffuse large B-cell lymphoma, Richter’s transformation, or transformed follicular lymphoma that came back or continued to grow despite prior treatment.
  • At least 3 weeks must pass between the completion of previous therapies and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • 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

20-081

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators