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Anti-infective agent

pyrimethamine for Small Lymphocytic Leukemia

Phase 1 & 2

Waitlist Available

Led By Jennifer Brown, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up disease were evaluated weekly in 1st 28 days, and every 2 weeks in 2nd cycle then monthly. median treatment duration is 1.07 months with range 0.23-9.99 months.

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of an antibiotic called pyrimethamine in treating people with chronic lymphocytic leukemia or small lymphocytic lymphoma. Previous studies have shown that pyrimethamine may kill leukemia cells by targeting a protein called STAT3. The goal of this trial is to find the highest dose of pyrimethamine that can be given safely to patients without severe side effects, and to assess whether the drug results in clinical benefit or tumor responses.

Eligible Conditions

Small Lymphocytic Leukemia
Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ disease were evaluated weekly in 1st 28 days, and every 2 weeks in 2nd cycle then monthly. median treatment duration is 1.07 months with range 0.23-9.99 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~disease were evaluated weekly in 1st 28 days, and every 2 weeks in 2nd cycle then monthly. median treatment duration is 1.07 months with range 0.23-9.99 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and disease were evaluated weekly in 1st 28 days, and every 2 weeks in 2nd cycle then monthly. median treatment duration is 1.07 months with range 0.23-9.99 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Maximum Tolerated Dose (MTD)

Phase II: Overall Response Rate (ORR)

Secondary outcome measures

Incidence of Grade 3 or Higher Treatment-Related Toxicity

Median Progression Free Survival (PFS)

Side effects data

From 2023 Phase 1 & 2 trial • 20 Patients • NCT01066663

100%

Anorexia

100%

Anemia

100%

Creatinine increased

67%

Platelet count decreased

67%

Dyspnea

33%

Dehydration

33%

Hyponatremia

33%

Alkaline phosphatase increased

33%

Blood bilirubin increased

33%

Alanine aminotransferase increased

33%

Chills

33%

Fatigue

33%

Neck pain

33%

Hyperglycemia

33%

Hypercalcemia

33%

Neutrophil count decreased

33%

Hyperkalemia

33%

Weight loss

33%

Nausea

33%

Tremor

33%

Cough

33%

Epistaxis

33%

Aspartate aminotransferase increased

100%

80%

60%

40%

20%

Study treatment Arm

DL1: Pyrimethamine 12.5 mg

DL3: Pyrimethamine 50 mg

DL2: Pyrimethamine 25 mg

Trial Design

3Treatment groups

Experimental Treatment

Group I: DL3: Pyrimethamine 50 mgExperimental Treatment1 Intervention

Pyrimethamine single daily oral 50 mg dose.

Group II: DL2: Pyrimethamine 25 mgExperimental Treatment1 Intervention

Pyrimethamine single daily oral 25 mg dose.

Group III: DL1: Pyrimethamine 12.5 mgExperimental Treatment1 Intervention

Pyrimethamine single daily oral 12.5 mg dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pyrimethamine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,928 Total Patients Enrolled

Lymphoma Research FoundationOTHER

2 Previous Clinical Trials

73 Total Patients Enrolled

Beth Israel Deaconess Medical CenterOTHER

836 Previous Clinical Trials

13,010,316 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other studies that have examined the efficacy of pyrimethamine?

"Currently, 5 pyrimethamine trials are underway with 2 of these studies in Phase 3. These clinical investigations span 6 diverse locations, mainly situated around Boston Massachusetts."

Answered by AI

What are the objectives of this clinical experiment?

"The main aim of this clinical trial is to establish the Maximum Tolerated Dose (MTD) within 10 days. Secondary objectives include determining Median Progression Free Survival (PFS) and assessing the toxicity profile of pyrimethamine in relapsed CLL/SLL, both acutely and over prolonged daily dosing. Moreover, progression-free survival following pyrimethamine for the treatment of relapsed CLL/SLL will be measured."

Answered by AI

What is the highest number of participants for this trial?

"The clinical trial has concluded its search for participants; the original posting was made on March 1st 2010 and it was most recently edited on November 14th 2022. For those seeking alternate studies, 1522 trials are currently recruiting patients with leukemia, lymphocytic chronic B-cell illnesses while a further 5 trials are actively looking to recruit individuals taking pyrimethamine."

Answered by AI

Are there any opportunities for interested individuals to enroll in this medical trial?

"As per clinicaltrials.gov, this medical experiment is no longer looking for participants - the initial post was on March 1st 2010 and it was last updated on November 14th 2022. However, 1527 other trials are in need of volunteers at this very moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jennifer R. Brown, MD, PhD 2010. "Pyrimethamine for the Treatment of Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01066663.