Trial Outcomes & Findings for Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission (NCT NCT01096602)

Last Updated: 2026-07-14

Results Overview

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.)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

6 months after the last vaccine, up to 9 months

Results posted on

2026-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 DC AML Fusion Vaccine DC AML Vaccine: Group 1: 2-3 doses of the vaccine at 4 week intervals
Enrollment Through Vaccine Generation STARTED	63
Enrollment Through Vaccine Generation COMPLETED	19
Enrollment Through Vaccine Generation NOT COMPLETED	44
Treatment With At Least One Vaccine STARTED	19
Treatment With At Least One Vaccine COMPLETED	17
Treatment With At Least One Vaccine NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 DC AML Fusion Vaccine DC AML Vaccine: Group 1: 2-3 doses of the vaccine at 4 week intervals
Enrollment Through Vaccine Generation Not eligible for vaccine generation	44
Treatment With At Least One Vaccine Progression prior to vaccine	2

Baseline Characteristics

Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 / Patients Treated n=17 Participants Patients treated with at least 1 vaccine
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=9 Participants
Age, Categorical >=65 years	4 Participants n=9 Participants
Age, Continuous	63 years n=9 Participants
Sex: Female, Male Female	10 Participants n=9 Participants
Sex: Female, Male Male	7 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	1 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	1 Participants n=9 Participants
Race (NIH/OMB) White	14 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants
Region of Enrollment United States	17 participants n=9 Participants

PRIMARY outcome

Timeframe: 6 months after the last vaccine, up to 9 months

Outcome measures

Outcome measures
Measure	Group 1 / Patients Treated n=17 Participants Patients treated with at least 1 vaccine
Number of Participants With Adverse Events Associated With DC/AML Tumor Vaccine	13 Participants

SECONDARY outcome

Timeframe: 6 months after last vaccine, up to 9 months

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.

Outcome measures

Outcome measures
Measure	Group 1 / Patients Treated n=16 Participants Patients treated with at least 1 vaccine
Immune Expansion After Vaccination AML-specific CD4+ T-cells	5.4 fold change in AML-specific T-cells Interval 0.5 to 9.0
Immune Expansion After Vaccination AML-specific CD8+ t-cells	15.7 fold change in AML-specific T-cells Interval 2.5 to 20.0

SECONDARY outcome

Timeframe: 6 months after last vaccine, up to 9 months

To correlate levels of circulating activated and regulatory T cells (CD4 and CD8 t-cells) with immunologic response following vaccination

Outcome measures

Outcome measures
Measure	Group 1 / Patients Treated n=13 Participants Patients treated with at least 1 vaccine
Number of Patients Who Had Expansion of Leukemia-Specific CD4 and CD8 T-cells After Vaccination	0 Participants

SECONDARY outcome

Timeframe: 2 years

To define anti-tumor effects by determining time to disease progression. Participants were monitored for progression and survival every 3 months through 2 years.

Outcome measures

Outcome measures
Measure	Group 1 / Patients Treated n=17 Participants Patients treated with at least 1 vaccine
Disease Response Progressed Prior to 2 Years	3 Participants
Disease Response Alive and in Remission at 2 Years	14 Participants

Adverse Events

Group 1 / Patients Treated

Serious events: 0 serious events

Other events: 13 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1 / Patients Treated n=17 participants at risk Patients treated with at least 1 vaccine
General disorders Injection Site Reaction	11.8% 2/17 • Number of events 3 • 6 Months After Last Dose of Vaccine, up to 9 Months for Serious and Other (Non Serious) Adverse Events 2 years for All-Cause Mortality 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.) Following the 9 months, participants were no longer followed for adverse events and only followed for progression and survival (for up to 2 years), reported under endpoint 4.
Investigations Leukopenia	17.6% 3/17 • Number of events 5 • 6 Months After Last Dose of Vaccine, up to 9 Months for Serious and Other (Non Serious) Adverse Events 2 years for All-Cause Mortality 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.) Following the 9 months, participants were no longer followed for adverse events and only followed for progression and survival (for up to 2 years), reported under endpoint 4.
Skin and subcutaneous tissue disorders Urticaria	5.9% 1/17 • Number of events 4 • 6 Months After Last Dose of Vaccine, up to 9 Months for Serious and Other (Non Serious) Adverse Events 2 years for All-Cause Mortality 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.) Following the 9 months, participants were no longer followed for adverse events and only followed for progression and survival (for up to 2 years), reported under endpoint 4.
Investigations Eosinophilia	5.9% 1/17 • Number of events 3 • 6 Months After Last Dose of Vaccine, up to 9 Months for Serious and Other (Non Serious) Adverse Events 2 years for All-Cause Mortality 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.) Following the 9 months, participants were no longer followed for adverse events and only followed for progression and survival (for up to 2 years), reported under endpoint 4.
Investigations Elevated TSH	11.8% 2/17 • Number of events 3 • 6 Months After Last Dose of Vaccine, up to 9 Months for Serious and Other (Non Serious) Adverse Events 2 years for All-Cause Mortality 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.) Following the 9 months, participants were no longer followed for adverse events and only followed for progression and survival (for up to 2 years), reported under endpoint 4.
Investigations Platelet Count, Decreased	11.8% 2/17 • Number of events 3 • 6 Months After Last Dose of Vaccine, up to 9 Months for Serious and Other (Non Serious) Adverse Events 2 years for All-Cause Mortality 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.) Following the 9 months, participants were no longer followed for adverse events and only followed for progression and survival (for up to 2 years), reported under endpoint 4.
Skin and subcutaneous tissue disorders Pruritis	5.9% 1/17 • Number of events 1 • 6 Months After Last Dose of Vaccine, up to 9 Months for Serious and Other (Non Serious) Adverse Events 2 years for All-Cause Mortality 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.) Following the 9 months, participants were no longer followed for adverse events and only followed for progression and survival (for up to 2 years), reported under endpoint 4.
Investigations Increased Monocytes	5.9% 1/17 • Number of events 1 • 6 Months After Last Dose of Vaccine, up to 9 Months for Serious and Other (Non Serious) Adverse Events 2 years for All-Cause Mortality 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.) Following the 9 months, participants were no longer followed for adverse events and only followed for progression and survival (for up to 2 years), reported under endpoint 4.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • Number of events 1 • 6 Months After Last Dose of Vaccine, up to 9 Months for Serious and Other (Non Serious) Adverse Events 2 years for All-Cause Mortality 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.) Following the 9 months, participants were no longer followed for adverse events and only followed for progression and survival (for up to 2 years), reported under endpoint 4.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Number of events 1 • 6 Months After Last Dose of Vaccine, up to 9 Months for Serious and Other (Non Serious) Adverse Events 2 years for All-Cause Mortality 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.) Following the 9 months, participants were no longer followed for adverse events and only followed for progression and survival (for up to 2 years), reported under endpoint 4.

Additional Information

Emma Logan, Director of Nursing

Beth Israel Deaconess Medical Center

Phone: 617-667-9920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place