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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission
- ClinicalTrials.gov ID
- NCT01096602
- Acronym / sponsor ID
- 09-412
- Conditions
- Acute Myelogenous Leukemia, AML
- Keywords
- Dendritic Cell/AML vaccine, CT-011
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Medivation, Inc., The Leukemia and Lymphoma Society, Dana-Farber Cancer Institute
- Study start
- May 2010
- Primary completion
- Dec 2023 (actual)
- Study completion
- Jun 2025 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Posted 14 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: DC AML VaccineDC AML Fusion Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC AML VaccineGroup 1: 2-3 doses of the vaccine at 4 week intervals | Biological | Group 1 |
Primary outcome
Number of Participants With Adverse Events Associated With DC/AML Tumor Vaccine
Time frame: 6 months after the last vaccine, up to 9 months
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.)
3 secondary outcomes
Immune Expansion After Vaccination
Time frame: 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
Time frame: 6 months after last vaccine, up to 9 months
Disease Response
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33394722Shallis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacalyn Rosenblatt, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events Associated With DC/AML Tumor Vaccine (time frame: 6 months after the last vaccine, up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.