Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00001144 · ClinicalTrials.gov registry record · Phase 2
Modified Bone Marrow Stem Cell Transplantation for Chronic Myelogenous Leukemia
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00001144 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 50 participants.
The verdict
NCT00001144, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
This study will investigate the safety and effectiveness of a new stem cell transplant procedure for treating chronic myelogenous leukemia (CML). Transplantation of donated stem cells (cells produced by the bone marrow that mature into the different blood components-white cells, red cells and platelets) is a very effective treatment for CML. However, despite its success in a large number of patients, there is still a significant risk of death from the procedure. In addition, it results in sterility and leaves patients at increased risk for other cancers and for eye cataracts. These complications result from the intensive chemotherapy and radiation patients receive before the transplant to rid the body of cancer cells. In this study, radiation will not be used and chemotherapy drugs will be given in lower doses to try to reduce the dangers of the procedure. Patients with CML will be tested for matching with a donor (family member) and will undergo a medical history, physical examination and several tests (e.g., breathing tests, X-rays, and others) to determine eligibility for the study. Participants will then undergo apheresis to collect lymphocytes (white blood cells important in the immune system). In apheresis, whole blood is drawn through a needle in the arm, similar to donating a unit of blood. The required component-in this case, lymphocytes-are separated and removed, and the rest of the blood is returned through a needle in the other arm. Each day starting five days before the transplant, the donor will be given an injection of G-CSF, a drug that releases stem cells from the bone marrow into the blood stream. The cells will be collected after the fifth injection and again after a sixth injection the following day. Meanwhile, patients will be given cyclophosphamide and fludarabine, and perhaps anti-thymocyte globulin, to prevent rejection of the donated cells. On the day of the transplant, patients will be given cyclosporin to prevent graft-versus-host-dise
Interventions
- DRUG Modified bone marrow stem cell transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 1999-10 |
| Est. Completion | 2002-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001144
The ClinicalTrials.gov registry entry for NCT00001144 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which Modified bone marrow stem cell transplantation is the first listed.
NCT00001144 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001144 about?
NCT00001144 is a clinical study titled "Modified Bone Marrow Stem Cell Transplantation for Chronic Myelogenous Leukemia". This study will investigate the safety and effectiveness of a new stem cell transplant procedure for treating chronic myelogenous leukemia (CML). Transplantation of donated stem cells (cells produced by the bone marrow that mature into the different blood components-white cells, red cells and plate...
What is the current status of trial NCT00001144?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 1999-10. Estimated completion is 2002-10.
What interventions are being tested in trial NCT00001144?
The interventions under investigation include: Modified bone marrow stem cell transplantation (DRUG).
Who is sponsoring clinical trial NCT00001144?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
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.