Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00566696 · ClinicalTrials.gov registry record · Phase 2
Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT00566696 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 73 participants.
The verdict
NCT00566696, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study Summary
Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling donor available and/or are unable to identify an acceptable unrelated HLA matched donor through the registries in a timely manner. Another option is haploidentical transplant using a partially matched family member donor. Although haploidentical transplant has proven curative in many patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including 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 body tissues of the patient (the host) 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 grow, leaving the patient at high-risk for significant infection. For these reasons, a primary focus for researchers is to engineer the graft to provide a T cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to facilitate immune reconstitution and graft integrity. Building on prior institutional trials, this study will provide patients with a haploidentical (HAPLO) graft engineered to specific T cell target values using the CliniMACS system. A reduced intensity, preparative regimen will be used in an effort to reduce regimen-related toxicity and mortality. The primary aim of the study is to help improve overall survival with haploidentical stem cell transplant in this high risk patient population by 1) limiting the complication of graft versus host disease (GVHD), 2) enhancing post-transplant immune reconstitution, and 3) reducing non-relapse mortality.
Interventions
- DRUG Fludarabine
- DEVICE CliniMACS
- PROCEDURE Stem cell transplantation
- DRUG Thioplex®
- DRUG L-phenylalanine mustard
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2007-12-14 |
| Est. Completion | 2020-02-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00566696
The ClinicalTrials.gov registry entry for NCT00566696 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 73 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 5 interventions - of which Fludarabine is the first listed.
NCT00566696 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00566696 about?
NCT00566696 is a clinical study titled "Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies". Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling donor available and/or are unable to identify an acceptable unrelated HLA matched donor through the...
What is the current status of trial NCT00566696?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2007-12-14. Estimated completion is 2020-02-06.
What interventions are being tested in trial NCT00566696?
The interventions under investigation include: Fludarabine (DRUG), CliniMACS (DEVICE), Stem cell transplantation (PROCEDURE), Thioplex® (DRUG), L-phenylalanine mustard (DRUG).
Who is sponsoring clinical trial NCT00566696?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.