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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: Clinical Trial Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess one year relapse-free survival (RFS) in patients undergoing HSCT (hematopoietic stem cell transplantation) using the TJU 2 step-approach with two donors. Survival will be estimated by the Kaplan-Meier method. All estimates of rates will be presented with corresponding confidence intervals. For 1 year RFS rates, the method of Atkinson and Brown will be used to allow for the two-stage design; otherwise the method of Conover.
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 |
Why NCT01532635 stopped before completion
NCT01532635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which Total Body Irradiation (TBI) is the first listed.
NCT01532635 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01532635's enrollment target sits among peer trials
4 2001st of 2000 the lowest 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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