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NCT00710892 · ClinicalTrials.gov registry record · Phase 1
CASPALLO: Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene
A Phase 1 study of Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT00710892 is a Phase 1 study of Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 10 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00710892, a Phase 1 study of Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
Patients are being asked to participate in this study because they will be receiving a stem cell transplant as treatment for their disease. As part of the stem cell transplant, they will be given very strong doses of chemotherapy, which will kill off all their existing stem cells. Stem cells are created in the bone marrow. They grow into different types of blood cells that we need, including red blood cells, white blood cells, and platelets. We have identified a close relative of the patients whose stem cells are not a perfect match for the patient, but can be used. This type of transplant is called "allogeneic", meaning that the cells come from a donor. With this type of donor who is not a perfect match, there is typically an increased risk of developing graft-versus-host disease (GvHD) and a longer delay in the recovery of the immune system. GvHD is a serious and sometimes fatal side effect of stem cell transplant. GvHD occurs when the new donor cells recognize that the body tissues of the patient are different from those of the donor. In the laboratory, we have seen that cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. To get the iCasp9 into the T cells, we insert it using a virus called a retrovirus that has been made for this study. The drug (AP1903) that will be used to "activate" the iCasp9 is an experimental drug that has been tested in a study in normal donors, with no bad side effects. We hope we can use this drug to kill the T cells. Other drugs that kill or damage T cells have helped GvHD in many studies. However we do not yet know whether AP1903 will kill T cells in humans, even though it has worked in our experimental studies on human cells in animals. Nor do we know whether killing the T cells will help the GvHD. Because of this uncertainty, patients who develop significant GvHD will also receive standard therapy for this complication, in addition to the experimental drug. We hope that having
Conditions Studied
Interventions
- BIOLOGICAL Allodepleted T Cells
Study Locations (2)
Texas
- Texas Children's Hospital - Houston
- The Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-12 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00710892
The ClinicalTrials.gov registry entry for NCT00710892 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (95% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Allodepleted T Cells is the first listed.
NCT00710892 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00710892 about?
NCT00710892 is a clinical study titled "CASPALLO: Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene". Patients are being asked to participate in this study because they will be receiving a stem cell transplant as treatment for their disease. As part of the stem cell transplant, they will be given very strong doses of chemotherapy, which will kill off all their existing stem cells. Stem cells are cre...
What is the current status of trial NCT00710892?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2008-12. Estimated completion is 2026-07.
What conditions does trial NCT00710892 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Chronic Myeloid Leukemia.
What interventions are being tested in trial NCT00710892?
The interventions under investigation include: Allodepleted T Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00710892?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00710892 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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