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NCT01384513 · ClinicalTrials.gov registry record · Phase 2
A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01384513 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 40 participants.
The verdict
NCT01384513, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This phase II trial studies how well reduced intensity donor stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
Interventions
- DRUG Fludarabine
- RADIATION Total Body Irradiation (TBI)
- DRUG Busulfan
- DRUG Cyclophosphamide (CY)
- BIOLOGICAL Donor Lymphocyte Infusion (DLI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-08-04 |
| Est. Completion | 2022-11-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01384513
The ClinicalTrials.gov registry entry for NCT01384513 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 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 Fludarabine is the first listed.
NCT01384513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01384513 about?
NCT01384513 is a clinical study titled "A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies". This phase II trial studies how well reduced intensity donor stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including...
What is the current status of trial NCT01384513?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2011-08-04. Estimated completion is 2022-11-16.
What interventions are being tested in trial NCT01384513?
The interventions under investigation include: Fludarabine (DRUG), Total Body Irradiation (TBI) (RADIATION), Busulfan (DRUG), Cyclophosphamide (CY) (DRUG), Donor Lymphocyte Infusion (DLI) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01384513?
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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