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NCT00574509 · ClinicalTrials.gov registry record · Phase 1
Hematopoietic Stem Cell Transplant for Recurrent Non-Hodgkin's Lymphoma
A Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT00574509: Completed Phase 1 study, sponsored by University of Nebraska.
NCT00574509 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00574509, a Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety of 131I-anti-B1 Radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy and hematopoietic stem cell transplantation. The study will also compare the difference in response rates and time to treatment failure between historical control patients receiving high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem cell transplant and patients receiving radioimmunotherapy and high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem cell transplant. Patients will receive escalating doses of radioimmunotherapy with anti-B1 radiolabeled with 131Iodine, high-dose carmustine, etoposide, cytarabine and Melphalan (BEAM) chemotherapy, and autologous hematopoietic stem cell transplant.
Primary Outcome
Safety of 131I-anti-B1 radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy \& HSCT. Calculations will be made such that in a dose escation study, whole body radiation doses of 30, 45, 60, and 75cGy will result from the administration of the therapeutic activity of 131I-anti-B1.
Interventions
- DRUG BEAM
- RADIATION 131Iodine-Anti-B1 Radioimmunotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 1996-03-04 |
| Est. Completion | 2014-12-10 |
| Phase | Phase 1 |
What the finished NCT00574509 record still lists
NCT00574509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which BEAM is the first listed.
NCT00574509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00574509 about?
NCT00574509 is a clinical study titled "Hematopoietic Stem Cell Transplant for Recurrent Non-Hodgkin's Lymphoma". The purpose of this study is to assess the safety of 131I-anti-B1 Radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy and hematopoietic stem cell transplantation. The study will also compare the difference in response rates and time to treatment failure between historical contr...
What is the current status of trial NCT00574509?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 1996-03-04. Estimated completion is 2014-12-10.
What interventions are being tested in trial NCT00574509?
The interventions under investigation include: BEAM (DRUG), 131Iodine-Anti-B1 Radioimmunotherapy (RADIATION).
Who is sponsoring clinical trial NCT00574509?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00574509's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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