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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: Completed Phase 1 study of Hematologic Malignancies, sponsored by Dana-Farber Cancer Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MTD of bortezomib was evaluated at 3 dose levels: Dose level 1: 1.0 mg/m\^2 Dose level 2: 1.3 mg/m\^2 Dose level 3: 1.5 mg/m\^2 Cohorts of 3-5 pts were enrolled at each dose level. At any dose level, if no DLT in the first 3, 4, or 5 pts, then dose escalation would occur. If 3 evaluable pts in cohort, and 1 of 3 experiences DLT then 2 additional pts treated at the same dose level. If \>=1 of 2 additional pts experience DLT then previous dose level will be MTD. If no DLT in additional 2 pts
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 |
What the finished NCT00369226 record still lists
NCT00369226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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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Where NCT00369226's enrollment target sits among peer trials
45 28th of 45 higher than 18 of 45 other Hematologic Malignancies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Malignancies 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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