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NCT00369226 · ClinicalTrials.gov registry record · Phase 1
Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation
A Phase 1 study of Hematologic Malignancies, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 2
- Study locations
NCT00369226 is a Phase 1 study of Hematologic Malignancies that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 45 participants, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00369226, a Phase 1 study of Hematologic Malignancies, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine if Velcade (also known as bortezomib) can help prevent graft versus host disease (GVHD) developing after transplantation. This is done by using a combination of three immune suppressive medications: Velcade, tacrolimus and methotrexate. Stem cell transplantation is one of the options for patients with cancer of the blood or blood forming organs. Recently, allogeneic stem cell transplants have been performed using lower doses of chemotherapy and radiotherapy: non-myeloablative or "mini" transplants. GVHD is a significant problem that may occur even after "mini" transplantations. Information from other research studies, suggests that Velcade may help to reduce the risk of developing GVHD when given early after transplantation.
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG Methotrexate
- DRUG Bortezomib (Velcade)
- PROCEDURE blood stem cell transplantation
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2006-08 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00369226
The ClinicalTrials.gov registry entry for NCT00369226 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (98% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hematologic Malignancies appearing as the primary indexed condition, and to 4 interventions - of which Tacrolimus is the first listed.
NCT00369226 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00369226 about?
NCT00369226 is a clinical study titled "Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation". The purpose of this study is to determine if Velcade (also known as bortezomib) can help prevent graft versus host disease (GVHD) developing after transplantation. This is done by using a combination of three immune suppressive medications: Velcade, tacrolimus and methotrexate. Stem cell transplanta...
What is the current status of trial NCT00369226?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2006-08. Estimated completion is 2011-09.
What conditions does trial NCT00369226 study?
This clinical trial studies the following conditions: Hematologic Malignancies.
What interventions are being tested in trial NCT00369226?
The interventions under investigation include: Tacrolimus (DRUG), Methotrexate (DRUG), Bortezomib (Velcade) (DRUG), blood stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00369226?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00369226 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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