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NCT01239368 · ClinicalTrials.gov registry record · Phase 1
Th1/Tc1 Immunotherapy Following Stem Cell Transplantation in Multiple Myeloma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01239368: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01239368 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01239368, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
Background: \- Cancer development is associated with problems in immune system functions, which prevent the body from attacking and destroying the abnormal cells that lead to tumor growth. Research has suggested that certain white blood cells, known as Th1 (type 1 T helper cells) and Th2 T cells (type 2 T helper cells), are affected in individuals with some kinds of cancer -- when the proportion of Th2 cells is greater than Th1 cells, the immune systems ability to fight off the growth of malignant tumors is weakened. Researchers are interested in determining if an infusion of specially modified Th1 cells, in addition to stem cell transplant, is a safe and effective treatment for individuals with forms of multiple myeloma that might not respond well to standard treatments alone. Objectives: \- To determine the safety and effectiveness of the infusion of modified Th1 white blood cells, in conjunction with standard treatment, as a treatment for individuals who have been diagnosed with high-risk forms of multiple myeloma. Eligibility: * Individuals age 18 to 75 who have been newly diagnosed with high-risk multiple myeloma and who have received no or minimal treatment (Cohort A). * Individuals age 18 to 75 who have relapsed multiple myeloma, as defined by measurable disease after at least 2 prior treatment regimens. Design: * Participants will be screened with a medical history, physical examination, blood and urine tests, and imaging studies. Some participants may also have a bone marrow or other type biopsy to evaluate the state of their disease. * White blood cells will be collected from the participants through an apheresis procedure, which will collect and separate the white blood cells and return the rest of the blood to the participant. * The collected cells will be grown and expanded under special conditions in the laboratory and stored frozen until participants receive standard of care treatment for multiple myeloma, including a stem cell transplant. * Pa
Interventions
- PROCEDURE Adoptive Immunotherapy
- BIOLOGICAL Rapamycin-Generated Autologous Th1/Tc1 Cells (modified primary human T cells)
- BIOLOGICAL Th1/Tc1 Rapa Cell Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2010-11-10 |
| Est. Completion | 2017-08-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01239368
The ClinicalTrials.gov registry entry for NCT01239368 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Adoptive Immunotherapy is the first listed.
NCT01239368 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01239368 about?
NCT01239368 is a clinical study titled "Th1/Tc1 Immunotherapy Following Stem Cell Transplantation in Multiple Myeloma". Background: \- Cancer development is associated with problems in immune system functions, which prevent the body from attacking and destroying the abnormal cells that lead to tumor growth. Research has suggested that certain white blood cells, known as Th1 (type 1 T helper cells) and Th2 T cells (t...
What is the current status of trial NCT01239368?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2010-11-10. Estimated completion is 2017-08-16.
What interventions are being tested in trial NCT01239368?
The interventions under investigation include: Adoptive Immunotherapy (PROCEDURE), Rapamycin-Generated Autologous Th1/Tc1 Cells (modified primary human T cells) (BIOLOGICAL), Th1/Tc1 Rapa Cell Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT01239368?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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