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NCT01532635 · ClinicalTrials.gov registry record · Phase 2
A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT01532635 is a Phase 2 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 4 participants.
The verdict
NCT01532635, a Phase 2 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
This phase II clinical trial studies how well two donors stem cell transplant work in treating patients with high-risk hematologic malignancies. After receiving radiation to help further treat the disease, patients receive a dose of donors' T cells. T cells can fight infection and react against cancer cells. Two days after donors' T cells are given, patients receive cyclophosphamide (CY) to help destroy the most active T cells that may cause tissue damage (called graft versus host disease or GVHD). Some of the less reactive T cells are not destroyed by CY and they remain in the patient to help fight infection. A few days after the CY is given, patients receive donors' stem cells to help their blood counts recover. Using two donors' stem cell transplant instead of one donor may be more effective in treating patients with high-risk disease and may prevent the disease from coming back.
Interventions
- RADIATION Total Body Irradiation (TBI)
- DRUG Tacrolimus
- DRUG Mycophenolate Mofetil (MMF)
- DRUG Cyclophosphamide (CY)
- BIOLOGICAL Donor Lymphocyte Infusion (DLI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01532635
The ClinicalTrials.gov registry entry for NCT01532635 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Total Body Irradiation (TBI) is the first listed.
NCT01532635 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01532635 about?
NCT01532635 is a clinical study titled "A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives". This phase II clinical trial studies how well two donors stem cell transplant work in treating patients with high-risk hematologic malignancies. After receiving radiation to help further treat the disease, patients receive a dose of donors' T cells. T cells can fight infection and react against canc...
What is the current status of trial NCT01532635?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2012-03. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01532635?
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 NCT01532635?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
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