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NCT00429143 · ClinicalTrials.gov registry record · Phase 1
A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative
A Phase 1 study of Hematologic Malignancies, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT00429143: Completed Phase 1 study of Hematologic Malignancies, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT00429143 is a Phase 1 study of Hematologic Malignancies that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 27 participants, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00429143, a Phase 1 study of Hematologic Malignancies, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a partially-matched family donor. Patients receiving this type of transplant will receive chemotherapy and/or radiation to treat their disease. They will also receive their donor's cells in 2 parts. During the first part, the donor's lymphocytes will be exposed to one of the chemotherapy agents to help the patient become tolerant to the lymphocytes. In the second part of the transplant, the patient will receive their donor's stem cells to help recover their peripheral blood counts and establish long-term engraftment. The hypothesis of this study is that in partially-matched allogeneic transplant, there is a defined number of donor T-cells that can be treated and given to the recipient to avoid post-transplant infection without causing severe graft-versus-host disease.
Primary Outcome
To determine overall survival at 6 months post-transplant.
Conditions Studied
Interventions
- RADIATION Total Body Irradiation (TBI)
- DRUG Tacrolimus
- DRUG Mycophenolate Mofetil (MMF)
- DRUG Cyclophosphamide (CY)
- BIOLOGICAL Donor Lymphocyte Infusion (DLI)
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2006-01 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT00429143 record still lists
NCT00429143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hematologic Malignancies appearing as the primary indexed condition, and to 5 interventions - of which Total Body Irradiation (TBI) is the first listed.
NCT00429143 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00429143 about?
NCT00429143 is a clinical study titled "A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative". The purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a partially-matched family donor. Patients receiving this type of transplant will receive chemotherapy and/...
What is the current status of trial NCT00429143?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2006-01. Estimated completion is 2010-06.
What conditions does trial NCT00429143 study?
This clinical trial studies the following conditions: Hematologic Malignancies.
What interventions are being tested in trial NCT00429143?
The interventions under investigation include: Total Body Irradiation (TBI) (RADIATION), Tacrolimus (DRUG), Mycophenolate Mofetil (MMF) (DRUG), Cyclophosphamide (CY) (DRUG), Donor Lymphocyte Infusion (DLI) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00429143?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00429143 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00429143's enrollment target sits among peer trials
27 37th of 45 higher than 9 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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