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NCT00988013 · ClinicalTrials.gov registry record · NA
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
A NA study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT00988013 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 14 participants.
The verdict
NCT00988013, a NA study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a phase I study using Intensity Modulated Total Marrow Irradiation (IM-TMI) in addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high grade non Hodgkin's or Hodgkin's lymphoma, chronic myelogenous leukemia, and plasma cell leukemia. Because the subjects participating in this study have a disease that is severe and has a high risk of relapse even after transplant, the investigators propose to use a chemotherapy regimen (fludarabine/busulfan), the name for the combination of chemotherapy drugs that is given to patients prior to transplantation of the donor stem cells, along with intensity modulated radiation (IM-TMI) to the bone marrow. Total body irradiation (TBI) in conjunction with chemotherapy is a standard of care as a pre-conditioning regimen prior to bone marrow transplant (BMT) in patients with hematologic malignancies. However, TBI can cause severe side effects due to irradiation of organs such as the lenses of the eye, whole brain, lungs, liver, kidneys, heart, small bowel and oral cavity. IM-TMI allows for the delivery of adequate doses of radiation to the bone marrow while sparing other organs and therefore limiting radiation side effects. The irradiation, along with receiving the chemotherapy drugs will suppress the subject's immune system and kill off tumor cells, but will also intensify the effect of the conditioning regimen thus allowing the bone marrow transplantation to have a greater chance of being successful. No investigational drugs are used in this study. The investigational part of this study is the use of intensity modulated total marrow irradiation instead of conventional radiation. IMTMI can deliver 99% of the prescribed treatment to the targeted bones and reduce the doses of radiation to surrounding organs, as received in conventional TBI, by 29% to 65%.
Interventions
- RADIATION IM-TMI (3Gy)
- RADIATION IM-TMI (6Gy)
- RADIATION IM-TMI (9Gy)
- RADIATION IM-TMI (12Gy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-09 |
| Est. Completion | 2016-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00988013
The ClinicalTrials.gov registry entry for NCT00988013 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which IM-TMI (3Gy) is the first listed.
NCT00988013 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00988013 about?
NCT00988013 is a clinical study titled "Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies". This is a phase I study using Intensity Modulated Total Marrow Irradiation (IM-TMI) in addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high grade non Hodgkin's or Hodgkin's...
What is the current status of trial NCT00988013?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2009-09. Estimated completion is 2016-02.
What interventions are being tested in trial NCT00988013?
The interventions under investigation include: IM-TMI (3Gy) (RADIATION), IM-TMI (6Gy) (RADIATION), IM-TMI (9Gy) (RADIATION), IM-TMI (12Gy) (RADIATION).
Who is sponsoring clinical trial NCT00988013?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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