CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
pyrimethaminedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01066663
NCT01066663Phase 2Completed

A Phase I/II Study of Pyrimethamine, a STAT3 Inhibitor, for the Treatment of Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Dana-Farber Cancer Institute·interventional·Posted Feb 10, 2010·Updated Feb 22, 2023

In Brief

A Phase 2 clinical trial evaluating pyrimethamine for Chronic Lymphocytic Leukemia and Small Lymphocytic Leukemia. Completed, enrolled 20 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2010
Enrollment StartMar 1, 2010
Primary CompletionFeb 1, 2022
Study CompletionJan 1, 2023
TodayJul 2, 2026
Enrollment to primary: 11.9 yearsPosted 16.4 years ago

Interventions

pyrimethaminedrug

Taken orally once a day