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NCT01749293 · ClinicalTrials.gov registry record · Phase 2
Partially HLA Mismatched (Haploidentical) Allogeneic Bone Marrow Transplantation
A Phase 2 study, sponsored by University of Illinois at Chicago.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01749293 is a Phase 2 study that was terminated before completion, run by University of Illinois at Chicago. The registered enrollment target is 3 participants.
The verdict
NCT01749293, a Phase 2 study, was terminated before completion, sponsored by University of Illinois at Chicago.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Allogeneic stem cell transplantation is a potentially curative treatment for patients with many hematologic malignancies (e.g. leukemia, lymphoma, and myeloma with high risk of relapse). This process requires a suitable donor. The best case scenario involves an Human Leukocyte Antigen (HLA) matched sibling donor. However, this type of donor is not always available. Donor registries can provide another source for matched unrelated donors, but this may take valuable time delaying treatment for the transplant recipient. Donor availability remains a significant barrier to the use of allogeneic (from a donor) stem cell transplant. This issue disproportionately affects patients of minority backgrounds. Novel strategies to improve outcomes using alternative donors are desperately needed. Haploidentical transplants are an alternative which provides a readily available donor in the form of a partially HLA matched family member. This provides for more potential donors and the donors can be selected based on other factors that can play a role in transplant success (e.g. age, gender, KIR alloreactivity). Recent advances in transplant techniques have greatly improved success rates with haploidentical transplants although disease relapse has remained as issue. This trial aims to provide an alternative transplant option for patients with hematologic malignancies who require bone marrow transplantation but lack an HLA identical donor. The investigational component of this study is the combination of the Fludarabine/ Busulfan/ Total Body Irradiation conditioning regimen and the HLA Haploidentical Transplant with post-transplant Cyclophosphamide.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- RADIATION Total Body Irradiation
- PROCEDURE Haploidentical Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2012-08-30 |
| Est. Completion | 2014-05-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01749293
The ClinicalTrials.gov registry entry for NCT01749293 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01749293 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01749293 about?
NCT01749293 is a clinical study titled "Partially HLA Mismatched (Haploidentical) Allogeneic Bone Marrow Transplantation". Allogeneic stem cell transplantation is a potentially curative treatment for patients with many hematologic malignancies (e.g. leukemia, lymphoma, and myeloma with high risk of relapse). This process requires a suitable donor. The best case scenario involves an Human Leukocyte Antigen (HLA) matched ...
What is the current status of trial NCT01749293?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2012-08-30. Estimated completion is 2014-05-15.
What interventions are being tested in trial NCT01749293?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Total Body Irradiation (RADIATION), Haploidentical Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT01749293?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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