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NCT01096602 · ClinicalTrials.gov registry record · Phase 2
Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT01096602: Completed Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
NCT01096602 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01096602, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
Acute myelogenous leukemia (AML) arises from leukemia stem cells that are difficult to eradicate and serve as a reservoir for disease relapse following chemotherapy. A promising area of investigation is the development of immunotherapeutic approaches that stimulate the immune system to recognize leukemia stem cells as foreign and eliminate them. The purpose of this research study is to determine the safety of the Dendritic Cell AML Fusion Vaccine (DC AML vaccine) after participants have achieved a remission with chemotherapy. In this clinical trial, patients are treated with a tumor vaccine alone following standard of care chemotherapy. The DC AML vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. It is hoped that DC AML vaccine will prevent or delay the disease from coming back.
Primary Outcome
Participants were assessed for adverse events associated with treating AML patients with DC/AML fusion cells in the post-chemotherapy setting. Adverse event monitoring occurred monthly through 6 months following the last vaccine (up to 9 months) or until time of disease progression (whichever occurred first.)
Interventions
- BIOLOGICAL DC AML Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2010-05 |
| Est. Completion | 2024-06 |
| Phase | Phase 2 |
What the finished NCT01096602 record still lists
NCT01096602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which DC AML Vaccine is the first listed.
NCT01096602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01096602 about?
NCT01096602 is a clinical study titled "Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission". Acute myelogenous leukemia (AML) arises from leukemia stem cells that are difficult to eradicate and serve as a reservoir for disease relapse following chemotherapy. A promising area of investigation is the development of immunotherapeutic approaches that stimulate the immune system to recognize leu...
What is the current status of trial NCT01096602?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2010-05. Estimated completion is 2024-06.
What interventions are being tested in trial NCT01096602?
The interventions under investigation include: DC AML Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01096602?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01096602's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 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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