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NCT01518153 · ClinicalTrials.gov registry record · Phase 2
Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01518153: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01518153 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01518153, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn what dose of a kind of immune cell called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell transplant has the best results. The safety of this treatment will also be studied. This will be tested in patients with leukemia, MDS, lymphoma, Hodgkin disease, and multiple myeloma. These results are measured as helping to control the disease without severe graft-versus-host disease (GvHD). GvHD is when transplanted donor tissue attacks the tissues of the recipient's body. Fludarabine, melphalan, and alemtuzumab are commonly given before stem cell transplants: * Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die. * Melphalan is designed to bind to the DNA of cells, which may cause cancer cells to die. * Alemtuzumab is designed to weaken the immune system and reduce the risk of rejection of the transplant and graft-vs-host disease (GvHD). The donor infusion of T-cells is designed to help restore the immune system after the transplant, cause an immune reaction against the cancer, and reduce the risk of the cancer coming back.
Primary Outcome
Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Alemtuzumab
- DRUG Tacrolimus
- PROCEDURE Stem Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
Why NCT01518153 stopped before completion
NCT01518153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT01518153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01518153 about?
NCT01518153 is a clinical study titled "Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)". The goal of this clinical research study is to learn what dose of a kind of immune cell called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell transplant has the best results. The safety of this treatment will also be studied. This will be tested in patients with ...
What is the current status of trial NCT01518153?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2012-02. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01518153?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Alemtuzumab (DRUG), Tacrolimus (DRUG), Stem Cell Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT01518153?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01518153's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 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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