Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00013689 · ClinicalTrials.gov registry record · Phase 1
Pyrimethamine and Sulfadoxine for Treatment of Autoimmune Lymphoproliferative Syndrome
A Phase 1 study of Lymphoproliferative Disorder and Autoimmune Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT00013689 is a Phase 1 study of Lymphoproliferative Disorder and Autoimmune Disease that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 8 participants, below the 1,664-participant average among 12 other Lymphoproliferative Disorder trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00013689, a Phase 1 study of Lymphoproliferative Disorder and Autoimmune Disease, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and effectiveness of an antibiotic called Fansidar on autoimmune lymphoproliferative syndrome (ALPS). Patients with ALPS have enlarged lymph glands, spleen and/or liver, abnormal blood cell counts and overactive immune function. Current treatments are aimed at suppressing the immune system and improving symptoms, such as anemia (low red blood cell count) and low white blood cell and platelet counts. These treatments, however, are only partially effective and may have complications. Fansidar is a combination of two drugs, sulfadoxine and pyrimethamine, that is used to treat or prevent parasitic infections such as malaria. Recently a child with ALPS who was treated with Fansidar for a different illness had a marked shrinkage of the lymph organs. This study will examine whether Fansidar can shrink the lymph glands or spleen in patients with ALPS. Patients with ALPS between the ages of 4 and 70 years who have had lymph gland enlargement for at least 1 year and are not allergic to sulfa drugs may be eligible for this study. Candidates will be screened with a medical history and physical examination and blood tests. Females of reproductive age will have a urine pregnancy test. Participants will be evaluated at the NIH Clinical Center in Bethesda, MD, with blood tests and a computed tomography (CT) scan of the lymph nodes. For the CT scan, the patient lies on a table during an X-ray scan of the neck, part of the chest, and, if the spleen has not been removed, the stomach area. When these baseline tests are completed, patients will be given Fansidar pills to take once a week for 12 weeks. The dosage will be increased after 2 weeks and again after 4 weeks. At 2, 4, 6, 8 and 10 weeks after starting the treatment and 2 weeks after the last dose, patients will have blood drawn to check for possible side effects of therapy. Women will have a repeat urine pregnancy test at week 6 of treatment. Within a week before completing treatment or af
Conditions Studied
Interventions
- DRUG Fansidar (pyrimethamine and sulfadoxine)
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2001-03 |
| Est. Completion | 2003-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00013689
The ClinicalTrials.gov registry entry for NCT00013689 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,664-participant average among 12 other Lymphoproliferative Disorder trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Lymphoproliferative Disorder appearing as the primary indexed condition, and to 1 intervention - of which Fansidar (pyrimethamine and sulfadoxine) is the first listed.
NCT00013689 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00013689 about?
NCT00013689 is a clinical study titled "Pyrimethamine and Sulfadoxine for Treatment of Autoimmune Lymphoproliferative Syndrome". This study will evaluate the safety and effectiveness of an antibiotic called Fansidar on autoimmune lymphoproliferative syndrome (ALPS). Patients with ALPS have enlarged lymph glands, spleen and/or liver, abnormal blood cell counts and overactive immune function. Current treatments are aimed at sup...
What is the current status of trial NCT00013689?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2001-03. Estimated completion is 2003-03.
What conditions does trial NCT00013689 study?
This clinical trial studies the following conditions: Lymphoproliferative Disorder, Autoimmune Disease.
What interventions are being tested in trial NCT00013689?
The interventions under investigation include: Fansidar (pyrimethamine and sulfadoxine) (DRUG).
Who is sponsoring clinical trial NCT00013689?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00013689 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoproliferative Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas
RECRUITING · Phase 2
-
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
RECRUITING
-
Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19+ Lymphoproliferative Disorder (LPD)
RECRUITING · NA
-
Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas
RECRUITING · Phase 2
-
Registry of Older Patients With Cancer
RECRUITING
-
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
RECRUITING
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.