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NCT01066663 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01066663: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.

NCT01066663 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01066663, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study 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.

Primary Outcome

maximum tolerated dose and recommended Phase 2 dose pyrimethamine

Interventions

  • DRUG pyrimethamine

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-03
Est. Completion 2023-01
Phase Phase 1
Dana-Farber Cancer Institute

781 total trials

What the finished NCT01066663 record still lists

NCT01066663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which pyrimethamine is the first listed.

NCT01066663 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01066663 about?

NCT01066663 is a clinical study titled "Pyrimethamine for the Treatment of Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma". 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. Py...

What is the current status of trial NCT01066663?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-03. Estimated completion is 2023-01.

What interventions are being tested in trial NCT01066663?

The interventions under investigation include: pyrimethamine (DRUG).

Who is sponsoring clinical trial NCT01066663?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01066663's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01066663, the US trial registry maintained by the National Library of Medicine. NCT01066663 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.