NCT01096602CompletedPhase 2
Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 29 Mar 2010
- Start date
- May 2010
- Primary completion date
- Dec 2023
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT01096602
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 63
- From May 2010 to the primary completion date, Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals with a history of a different malignancy are ineligible except for circumstances outlined in the protocol document
- Prior to Cell Collection for Dendritic Cell Generation:
- Patients who choose to proceed with allogeneic or autologous transplant at the time of remission will not be vaccinated and will come off study
Other illness
- Active or history of autoimmune disorders/conditions including Type 1 diabetes. Type II diabetes, vitiligo or stable hyperthyroidism will not be considered exclusion criteria
- HIV positive
- Significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
- Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
Other
- Screening:
- Pregnant women
Who the study is looking for
- Screening:
- Patients with AML at initial diagnosis or at first relapse
- 18 years of age or older
- ECOG Performance Status 0-2
- Life expectancy of greater than 9 weeks
- Laboratory values within limits outlined in the protocol
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
- Prior to Cell Collections for Dendritic Cell Generation:
- Patients must have obtained complete remission with chemotherapy defined by the absence of circulating blasts, and less then 5% blasts on bone marrow examination following hematopoietic recovery
- Resolution of all chemotherapy related Grade III-IV toxicity as per CTC criteria 4.0
- Laboratory values as outlined in the protocol
- For patients with evidence of minimal residual disease prior to vaccination, assessment of minimal residual disease status by cytogenetics or FISH will be followed post vaccination
- Prior to Post-Chemotherapy Immunotherapy:
- Resolution of all chemotherapy related grade III-IV toxicity
- Laboratory values as outlined in the protocol
- At least 2 doses of fusion vaccine produced
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.