drugset
drugset / Trial / NCT01066663

Pyrimethamine for the Treatment of Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

NCT01066663 ↗

Phase 1/2 Completed 20 enrolled Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center · collabBrigham and Women's Hospital · collabLymphoma Research Foundation · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

In this research study we will start by looking for the highest dose of pyrimethamine that can be given safely to CLL patients without severe or unmanageable side effects. This dose will then be used for a larger Phase II study to assess the efficacy of pyrimethamine for the treatment of CLL/SLL. Pyrimethamine is an antibiotic that is used for the treatment of certain infections. Previous research studies have shown that pyrimethamine may target a protein in tumor cells, called STAT3, which may be important for the growth of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) cells. Pyrimethamine can kill CLL/SLL cells in the laboratory, and we are therefore undertaking this study to assess whether pyrimethamine will result in clinical benefit or tumor responses in CLL in patients.

Timeline

Start
2010-03
Primary completion
2022-02
Completion
2023-01

Drugs

EvaluationDrugModalityDoseRoute
Subject pyrimethamine Small molecule 12.5 mg Oral
Subject pyrimethamine Small molecule 25 mg Oral
Subject pyrimethamine Small molecule 50 mg Oral

Indications

chronic lymphocytic leukemia/small lymphocytic lymphoma