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NCT00571493 · ClinicalTrials.gov registry record · Phase 1
VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin's Lymphoma, or Mantle Cell Lymphoma
A Phase 1 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT00571493: Completed Phase 1 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, sponsored by University of Nebraska.
NCT00571493 is a Phase 1 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma that has completed, run by University of Nebraska. The registered enrollment target is 42 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00571493, a Phase 1 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I/II trial designed to study the toxicity and Maximum Tolerated Dose (MTD) of bortezomib in combination with BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) and autologous hematopoietic stem cell transplantation (ASCT) and to obtain a preliminary estimate of the response rate to this combination.
Primary Outcome
The maximum tolerated dose (MTD) is defined to be the dose cohort below which 3 of 6 patients experience dose limiting toxicity (DLT), or the highest dose cohort of 1.5 mg/m², if 2 DLT were not observed at any dose cohort.
Conditions Studied
Interventions
- DRUG Bortezomib
- DRUG BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2006-04-14 |
| Est. Completion | 2014-11-01 |
| Phase | Phase 1 |
What the finished NCT00571493 record still lists
NCT00571493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Bortezomib is the first listed.
NCT00571493 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT00571493 about?
NCT00571493 is a clinical study titled "VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin's Lymphoma, or Mantle Cell Lymphoma". This is a Phase I/II trial designed to study the toxicity and Maximum Tolerated Dose (MTD) of bortezomib in combination with BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) and autologous hematopoietic stem cell transplantation (ASCT) and to obtain a preliminary estimate of the response r...
What is the current status of trial NCT00571493?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2006-04-14. Estimated completion is 2014-11-01.
What conditions does trial NCT00571493 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma.
What interventions are being tested in trial NCT00571493?
The interventions under investigation include: Bortezomib (DRUG), BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) (DRUG).
Who is sponsoring clinical trial NCT00571493?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00571493 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00571493's enrollment target sits among peer trials
42 53rd of 102 higher than 50 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma 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.
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