Targeted drug therapies have greatly improved outcomes for patients with relapsed or
refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. However,
single drug therapies have limitations, therefore, the current study is evaluating a novel
oral combination of targeted drugs as a way of overcoming these limitations. This study will
determine the efficacy of the triple combination therapy, DTRM-555, in patients with R/R CLL
or R/R non-Hodgkin's lymphoma.
This study is being conducted in three parts: Phase Ia, Phase Ib and Phase II,
disease-specific expansion cohorts. Phase Ia explored escalating doses of a monotherapy of a
novel Bruton's Tyrosine Kinase (BTK) inhibitor, DTRMWXHS-12. Phase Ib explored two
combination therapies, DTRM-505 (DTRMWXHS-12 and everolimus) and DTRM-555 (DTRMWXHS-12,
everolimus and pomalidomide).
The current Phase II study will further examine the investigational triple combination
treatment, DTRM-555 for efficacy and safety. The study is being conducted in five
disease-specific cohorts: Activated B-Cell (ABC) Diffuse Large B-Cell Lymphoma, Germinal
Center B-Cell (GCB) Diffuse Large B-Cell Lymphoma, Richter's Transformation, transformed
Follicular Lymphoma, and relapsed or refractory Chronic Lymphocytic Leukemia.
The Primary Objective of the Phase II study is to determine the efficacy of the triple
combination therapy, DTRM-555, in the five disease-specific cohorts. The Secondary Objectives
are (1) to determine the safety of DTRM-555 in the cohorts and (2) to obtain the
pharmacokinetics of DTRM-555 (i.e., DTRMWXHS-12, everolimus and pomalidomide).
Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Richter's Transformation
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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