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NCT01773395 · ClinicalTrials.gov registry record · Phase 2
GVAX vs. Placebo for MDS/AML After Allo HSCT
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT01773395 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 123 participants.
The verdict
NCT01773395, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational intervention to learn whether the intervention, in this case, the GVAX vaccine, works in preventing MDS, CMML, or AML from relapsing after allogeneic stem cell transplantation. "Investigational" means that the vaccine is still being studied and that research doctors are trying to find out more about it-such as the side effects it may cause, and if the vaccine is effective. It also means that the FDA has not yet approved the vaccine for these types of cancer. Participants are being asked to participate in this trial because they have advanced myelodysplastic syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or acute myeloid leukemia (AML). Investigators have determined that participants are a candidate for an allogeneic stem cell transplant as treatment for MDS/CMML/AML. Allogeneic stem cell transplantation is a standard treatment for MDS/CMML/AML. It can be effective because the cells from the donor (also known as the graft) could form a new immune system that can fight against the MDS/CMML/AML cells in the body. This is also known as the "graft-versus-leukemia" or "GVL" effect. In patients with advanced MDS, CMML, or AML that is not in remission at the time of transplantation, relapse remains the number one cause of transplant failure. As such, this clinical trial is designed to assess whether adding a leukemia vaccine early after transplantation could stimulate donor cells to fight cancer and improve transplant outcomes. In recent years, researchers at the Dana-Farber Cancer Institute have discovered that GVAX, a vaccine made from the patient's own cancer cells engineered to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer. GM-CSF is a naturally occurring hormone in the body that helps the immune system fight infections and diseases. The GVAX vaccine is made in the laborat
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- BIOLOGICAL GVAX
- BIOLOGICAL Placebo Vaccine
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2013-01-08 |
| Est. Completion | 2021-11-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01773395
The ClinicalTrials.gov registry entry for NCT01773395 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT01773395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01773395 about?
NCT01773395 is a clinical study titled "GVAX vs. Placebo for MDS/AML After Allo HSCT". This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational intervention to learn whether the intervention, in this case, the GVAX vaccine, works in preventing MDS, CMML, or AML from relapsing after allogeneic stem cell transplantation. "In...
What is the current status of trial NCT01773395?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2013-01-08. Estimated completion is 2021-11-24.
What interventions are being tested in trial NCT01773395?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), GVAX (BIOLOGICAL), Placebo Vaccine (BIOLOGICAL), Allogeneic Hematopoietic Stem Cell Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT01773395?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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