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NCT00047060 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Transplant Therapy With Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome
A Phase 1 study of Mycosis Fungoides and Sezary Syndrome, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00047060 is a Phase 1 study of Mycosis Fungoides and Sezary Syndrome that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 5 participants, below the 163-participant average among 19 other Mycosis Fungoides trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00047060, a Phase 1 study of Mycosis Fungoides and Sezary Syndrome, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will investigate the safety and effectiveness of a modified donor stem cell transplantation procedure for treating advanced mycosis fungoides (MF), a lymphoma primarily affecting the skin, and Sezary syndrome (SS), a leukemic form of the disease. Donated stem cells (cells produced by the bone marrow that mature into the different blood components white cells, red cells and platelets) can cure patients with certain leukemias and lymphomas and multiple myeloma. These cells generate a completely new, functioning bone marrow. In addition, immune cells from the donor grow and generate a new immune system to help fight infections. The new immune cells also attack any residual tumor cells left in the body after intensive chemotherapy. However, stem cell transplantation carries a significant risk of death, because it requires completely suppressing the immune system with high-dose chemotherapy and radiation. In addition, lymphocytes from the donor may cause what is called graft vs. host disease (GvHD), in which these cells see the patient s cells as foreign and mount an immune response to destroy them. To try to reduce these risks, patients in this study will be given low-dose chemotherapy and no radiation, a regimen that is easier for the body to tolerate and involves a shorter period of complete immune suppression. In addition, a monoclonal antibody called Campath-1H will be given to target lymphocytes, including those that have become cancerous. Patients with advanced MF or SS who are between 18 and 70 years of age and have a matched family donor 18 years of age or older may be eligible for this study. Candidates will have a medical history, physical examination and blood tests, lung and heart function tests, X-rays of the chest, eye examination, and bone marrow sampling (withdrawal through a needle of about a tablespoon of marrow from the hip bone), and small skin biopsy (surgical removal of a piece of tissue for microscopic examination) or needle biopsy of
Conditions Studied
Interventions
- DRUG fludarabine
- DRUG Campath
- DRUG cyclosporine
- OTHER A matched peripheral donor stem cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2002-07-30 |
| Est. Completion | 2019-01-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00047060
The ClinicalTrials.gov registry entry for NCT00047060 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 163-participant average among 19 other Mycosis Fungoides trials with a reported enrollment target (97% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Mycosis Fungoides appearing as the primary indexed condition, and to 4 interventions - of which fludarabine is the first listed.
NCT00047060 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00047060 about?
NCT00047060 is a clinical study titled "Stem Cell Transplant Therapy With Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome". This study will investigate the safety and effectiveness of a modified donor stem cell transplantation procedure for treating advanced mycosis fungoides (MF), a lymphoma primarily affecting the skin, and Sezary syndrome (SS), a leukemic form of the disease. Donated stem cells (cells produced by the ...
What is the current status of trial NCT00047060?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2002-07-30. Estimated completion is 2019-01-24.
What conditions does trial NCT00047060 study?
This clinical trial studies the following conditions: Mycosis Fungoides, Sezary Syndrome.
What interventions are being tested in trial NCT00047060?
The interventions under investigation include: fludarabine (DRUG), Campath (DRUG), cyclosporine (DRUG), A matched peripheral donor stem cells (OTHER).
Who is sponsoring clinical trial NCT00047060?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00047060 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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