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NCT00145613 · ClinicalTrials.gov registry record · Phase 2
Haploidentical Stem Cell Transplant for Treatment Refractory Hematological Malignancies
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00145613 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 25 participants.
The verdict
NCT00145613, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
Relapsed disease is the most common cause of death in children with hematological malignancies. Patients who fail high-intensity conventional chemotherapeutic regimens or relapse after stem cell transplantation have a poor prognosis. Toxicity from multiple therapies and elevated leukemic/tumor burden usually make these patients ineligible for the aggressive chemotherapy regimens required for conventional stem cell transplantation. Alternative options are needed. One type of treatment being explored is called haploidentical transplant. Conventional blood or bone marrow stem cell transplant involves destroying the patient's diseased marrow with radiation or chemotherapy. Healthy marrow from a donor is then infused into the patient where it migrates to the bone marrow space to begin generating new blood cells. The best type of donor is a sibling or unrelated donor with an identical immune system (HLA "match"). However, most patients do not have a matched sibling available and/or are unable to identify an acceptable unrelated donor through the registries in a timely manner. In addition, the aggressive treatment required to prepare the body for these types of transplants can be too toxic for these highly pretreated patients. Therefore doctors are investigating haploidentical transplant using stem cells from HLA partially matched family member donors. Although haploidentical transplant has proven curative in many patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including graft versus host disease (GVHD), and infection due to delayed immune reconstitution. These can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize the patient's (the host) body tissues are different and attack these cells. Although too many T cells increase the possibility of GVHD, too few may cause the recipient's immune system to reconstitute slowly or the graft to fail to g
Interventions
- PROCEDURE Stem Cell Transplantation
- DEVICE Miltenyi Biotec CliniMACS
- DRUG Systemic chemotherapy and antibodies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2003-06 |
| Est. Completion | 2009-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00145613
The ClinicalTrials.gov registry entry for NCT00145613 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Stem Cell Transplantation is the first listed.
NCT00145613 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00145613 about?
NCT00145613 is a clinical study titled "Haploidentical Stem Cell Transplant for Treatment Refractory Hematological Malignancies". Relapsed disease is the most common cause of death in children with hematological malignancies. Patients who fail high-intensity conventional chemotherapeutic regimens or relapse after stem cell transplantation have a poor prognosis. Toxicity from multiple therapies and elevated leukemic/tumor burde...
What is the current status of trial NCT00145613?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2003-06. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00145613?
The interventions under investigation include: Stem Cell Transplantation (PROCEDURE), Miltenyi Biotec CliniMACS (DEVICE), Systemic chemotherapy and antibodies (DRUG).
Who is sponsoring clinical trial NCT00145613?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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