This study will evaluate a three-drug regimen for the treatment of relapsed B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL). The primary outcomes are how many patients respond to treatment or have a complete response (cancer no longer detectable). The study will take place in the United States.
B-cell NHL is a cancer involving abnormal growth of white blood cells known as B-cells. Cell growth is influenced by many types of signaling molecules, including kinases. Bruton’s tyrosine kinase (BTK) is involved in the growth of B-cells. DTRMWXHS-12 is a novel medication that blocks BTK.
This study combines DTRMWXHS-12 with immune-altering medications everolimus (Afinitor) and pomalidomide (Pomalyst). This three-drug regimen has been named DTRM-555. The study will evaluate this drug combination for the treatment of B-cell NHL or CLL which has relapsed (returned) or not responded to previous treatment. The primary outcomes are an overall and complete response to the treatment.
Who are they looking for?
This study is looking for 120 patients with relapsed NHL or CLL. Participants must agree to have their tumor sampled (biopsy) and those of childbearing age must agree to use strong birth control during the study and at least 4 weeks after the study.
Patients whose cancer has spread to the brain or spinal cord are not eligible. Patients with graft versus host disease following a stem cell transplant are not eligible. Patients who are pregnant or breastfeeding are not eligible. Patients must have adequate kidney and liver function, and must not have a bleeding or heart condition.
How will it work
All patients will be treated with the DTRM-555 regimen. All drugs will be given in tablet form. Out of every 28-day cycle, they will take the medications for 21 days. Patients will be followed for two years and their response to treatment will be evaluated.