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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: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary null hypothesis is that 2 year OS rate is at most 35%. This hypothesis will be rejected if the 95% confidence interval for year OS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35.
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 |
What the finished NCT01384513 record still lists
NCT01384513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT01384513 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01384513's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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