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NCT03042585 · ClinicalTrials.gov registry record · NA
Autologous Transplant Using Dose-Escalated Total Body Irradiation & Cyclophosphamide & Palifermin for NHL
A NA study, sponsored by Loyola University.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT03042585 is a NA study that has completed, run by Loyola University. The registered enrollment target is 17 participants.
The verdict
NCT03042585, a NA study, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
Most participants with a relapsed or refractory non-Hodgkin's lymphoma that receive an autologous transplant are likely to suffer a relapse because standard myeloablative preparative regimens are unable to produce a cure. The majority of these participants do not have a stem cell donor available, are too frail to undergo an allogeneic transplant, or refuse an allograft. Historically these participants with high risk non-Hodgkin's lymphoma have had a very poor outcome. To take advantage of the low transplant related mortality associated with an autologous transplantation, the investigators propose modifying the preparative regimen to make it more effective without increasing toxicity. By increasing the dose of radiation while administering the protective growth factor palifermin (Kepivance), the investigators hope to decrease the risk of relapse without increasing transplant related mortality. Three prospective randomized trials have studied different radiation schemes as a part of the TBI and cytoxan preparative regimen prior to allogeneic transplantation for patients with AML or CML. As a group these trials showed that higher doses of TBI in these older studies decreased the risk of relapse at the expense of VOD, GVHD, and CMV. Three retrospective studies have also postulated that higher dose radiation led to less risk of relapse.
Interventions
- RADIATION Total body irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2006-06 |
| Est. Completion | 2018-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03042585
The ClinicalTrials.gov registry entry for NCT03042585 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loyola University, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Total body irradiation is the first listed.
NCT03042585 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03042585 about?
NCT03042585 is a clinical study titled "Autologous Transplant Using Dose-Escalated Total Body Irradiation & Cyclophosphamide & Palifermin for NHL". Most participants with a relapsed or refractory non-Hodgkin's lymphoma that receive an autologous transplant are likely to suffer a relapse because standard myeloablative preparative regimens are unable to produce a cure. The majority of these participants do not have a stem cell donor available, ar...
What is the current status of trial NCT03042585?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2006-06. Estimated completion is 2018-12.
What interventions are being tested in trial NCT03042585?
The interventions under investigation include: Total body irradiation (RADIATION).
Who is sponsoring clinical trial NCT03042585?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
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