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NCT00003838 · ClinicalTrials.gov registry record · Phase 2
Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow
A Phase 2 study of Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 202
- Enrollment target
- 1
- Study location
NCT00003838 is a Phase 2 study of Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 202 participants, roughly in line with the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT00003838, a Phase 2 study of Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 202 participants
- Enrollment target
- 1
- Study location
Study Summary
The are a variety of cancerous diseases of the blood and bone marrow that can be potentially cured by bone marrow transplantation (BMT). Diseases like leukemia, lymphoma, and multiple myeloma are among the conditions that can be treated with BMT. Some patients with these diseases can be treated with medical chemotherapy alone. However, patients who relapse following chemotherapy are usually not curable with additional chemotherapy treatments. The only option known to provide a potential cure if this occurs is BMT. Allogenic transplants are cells collected from relatives of the patient. The transplant requires additional high intensity chemotherapy and radiation in order to destroy cancerous cells. In the process, many normal bone marrow cells are also destroyed. This is the reason for transplanting stem cells. The stem cells help to build new functioning bone marrow, red cells, white cells, and platelets. In addition, the immune cells from the donor are implanted into the recipient s body and help to fight off infection and kill remaining cancerous cells. Unfortunately, the powerful doses of chemotherapy and radiation therapy associated with allogenic BMT have toxic side effects and often make BMTs too dangerous to attempt in many patients. In order to reduce the complications of BMT, and make it a safer available option for patients with cancers of the blood and bone marrow, researchers have developed a new approach to the BMT. In this study researchers plan to use stem cells collected from the blood stream of patient s relatives rather than from the bone marrow (blood progenitor/stem cell transplant). In addition, researchers plan to use low doses of chemotherapy and no radiation therapy to reduce side effects. The majority of the cancer killing effect will be the responsibility of the stem cell transplant rather than the chemotherapy.
Conditions Studied
Interventions
- DRUG G-CSF
- DRUG Methotrexate
- DRUG Cyclosporine
- PROCEDURE T-cell replete PBPC allograft
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 1999-04-15 |
| Est. Completion | 2020-06-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00003838
The ClinicalTrials.gov registry entry for NCT00003838 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target. 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 5 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 4 interventions - of which G-CSF is the first listed.
NCT00003838 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00003838 about?
NCT00003838 is a clinical study titled "Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow". The are a variety of cancerous diseases of the blood and bone marrow that can be potentially cured by bone marrow transplantation (BMT). Diseases like leukemia, lymphoma, and multiple myeloma are among the conditions that can be treated with BMT. Some patients with these diseases can be treated wit...
What is the current status of trial NCT00003838?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 202 participants. The study started on 1999-04-15. Estimated completion is 2020-06-18.
What conditions does trial NCT00003838 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Myeloproliferative Disorders.
What interventions are being tested in trial NCT00003838?
The interventions under investigation include: G-CSF (DRUG), Methotrexate (DRUG), Cyclosporine (DRUG), T-cell replete PBPC allograft (PROCEDURE).
Who is sponsoring clinical trial NCT00003838?
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 NCT00003838 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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