Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00051311 · ClinicalTrials.gov registry record · Phase 2
Modified Stem Cell Transplant Procedure to Treat Patients With Blood and Immune System Cancers
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT00051311: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00051311 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 62 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00051311, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study will investigate the safety and effectiveness of a modified stem cell transplant procedure for treating cancers of the blood and immune system. Patients with cancers and pre-cancerous conditions originating in blood or immune system cells can sometimes benefit greatly from, and even be cured by, transplants of stem cells (cells produced by the bone marrow that mature into blood cells). In addition to producing new bone marrow and restoring normal blood production and immunity, the donated cells fight any residual tumor cells that might have remained in the body, in what is called a graft-versus-tumor effect. However, severe problems, and sometimes death, may follow these transplants as a result of the high-dose chemotherapy and radiation that accompany the procedure. Also, donated immune system cells called T cells sometimes attack healthy tissues in a reaction called graft-versus-host-disease (GVHD), damaging organs such as the liver, intestines and skin. This study will use the following strategies to try to reduce these risks: * induction chemotherapy to reduce patient's immunity in an attempt to prevent rejection of the donated stem cells; * reduced-intensity conditioning chemotherapy that is easier for the body to tolerate and involves a shorter period of complete immune suppression; * donation of immune cells called T helper type 2 (Th2) cells instead of T cells to try to reduce the risk of serious GVHD; * treatment with methotrexate and cyclosporine to try to reduce the risk of serious GVHD. Patients between 12 and 75 years of age with non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, chronic lymphocytic leukemia, chronic myelogenous leukemia, acute myelogenous leukemia, acute lymphocytic leukemia, myelodysplasia, idiopathic myelofibrosis, polycythemia vera, or chronic myelomonocytic leukemia may be eligible for this study. Candidates will have a medical history, physical and dental examinations, blood and urine tests (including a bl
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Doxorubicin
- DRUG Etoposide
- PROCEDURE Stem cell transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2003-01-03 |
| Est. Completion | 2014-09-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00051311
The ClinicalTrials.gov registry entry for NCT00051311 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00051311 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00051311 about?
NCT00051311 is a clinical study titled "Modified Stem Cell Transplant Procedure to Treat Patients With Blood and Immune System Cancers". This study will investigate the safety and effectiveness of a modified stem cell transplant procedure for treating cancers of the blood and immune system. Patients with cancers and pre-cancerous conditions originating in blood or immune system cells can sometimes benefit greatly from, and even be cu...
What is the current status of trial NCT00051311?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2003-01-03. Estimated completion is 2014-09-25.
What interventions are being tested in trial NCT00051311?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Doxorubicin (DRUG), Etoposide (DRUG), Stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00051311?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
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, the data changelog, or report a data error.