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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01518153
The ClinicalTrials.gov registry entry for NCT01518153 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT01518153 reports 0 study locations.
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.
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