Acute Myelogenous LeukemiaPhase 2NCT01096602
Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission
A Phase 2 study testing DC AML Vaccine in people with Acute Myelogenous Leukemia and AML, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, AML
- What is being tested?
- DC AML Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Screening:
- 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
- Pregnant women
- Individuals with a history of a different malignancy are ineligible except for circumstances outlined in the protocol document
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- Prior to Cell Collection for Dendritic Cell Generation:
- Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
- Patients who choose to proceed with allogeneic or autologous transplant at the time of remission will not be vaccinated and will come off study
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
Read the detailed description
- On this study participants will receive the DC AML vaccine and GM-CSF 4-8 weeks after completion of chemotherapy for acute myelogenous leukemia (AML). GM-CSF is a drug that stimulates white blood cells and is given with the DC AML Vaccine in an effort to enhance the effect of the vaccine. Participants will receive 2-3 doses of the vaccine at 4 week intervals.
- All participants will undergo the following procedures: Isolation of tumor cells by either bone marrow biopsy or blood draw; Initial chemotherapy for AML with standard therapy; Leukopheresis (collection of white blood cells from the blood).
- All participants will also have blood tests, a physical exam, and an electrocardiogram prior to each dose of vaccine.
- Four weeks following the final vaccination, participants will undergo a skin test called "delayed-type hypersensitivity" (DTH). This is an injection of the tumor cells under the skin to measure how the immune system responds. The tumor cells are broken up and irradiated to prevent their growth.
- Conditions
- Acute Myelogenous Leukemia, AML
- Being tested
- DC AML Vaccine
- Keywords
- Dendritic Cell/AML vaccine, CT-011
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC AML VaccineBiological
Group 1: 2-3 doses of the vaccine at 4 week intervals
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | DC AML Fusion Vaccine Receives: Biological: DC AML Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events Associated With DC/AML Tumor Vaccine
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.)
Measured: 6 months after the last vaccine, up to 9 months
Secondary outcomes (3)
Immune Expansion After Vaccination
To explore immunological response by measuring fold increase in AML-specific t-cells in patients who have achieved a chemotherapy-induced remission. Leukemia-specific t-cell expansion was measured in the blood and bone marrow by comparing samples taken prior to vaccination to samples taken at 1, 3 and 6 months following vaccination. Change from baseline to 6 months post last vaccination is reported below.
Measured: 6 months after last vaccine, up to 9 months
Number of Patients Who Had Expansion of Leukemia-Specific CD4 and CD8 T-cells After Vaccination
To correlate levels of circulating activated and regulatory T cells (CD4 and CD8 t-cells) with immunologic response following vaccination
Measured: 6 months after last vaccine, up to 9 months
Disease Response
To define anti-tumor effects by determining time to disease progression. Participants were monitored for progression and survival every 3 months through 2 years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2023
- Study completionJun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Medivation, Inc., The Leukemia and Lymphoma Society, Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Jacalyn Rosenblatt, Beth Israel Deaconess Medical Center
- Investigators
- Jacalyn Rosenblatt, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096602
- Sponsor's protocol ID
- 09-412
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2010
- Last updated
- 14 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637.
PubMed 33394722