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

Primary Purpose

Acute Myelogenous Leukemia, AML

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

DC AML Vaccine

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring Dendritic Cell/AML vaccine, CT-011

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Sites / Locations

Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group 1

Arm Description

DC AML Fusion Vaccine

Outcomes

Primary Outcome Measures

Toxicity

To assess the toxicity associated with treating AML patients with DC/AML fusion cells in the post-chemotherapy setting

Secondary Outcome Measures

Immune Response

To explore immunological response to DC/AML fusion vaccination in patients who have achieved a chemotherapy-induced remission.

T-cell and Immune Response

To correlate levels of circulating activated and regulatory T cells with immunologic response

Disease Response

To define anti-tumor effects by determining time to disease progression.

Full Information

NCT ID

NCT01096602

First Posted

March 29, 2010

Last Updated

June 16, 2023

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Institutes of Health (NIH), Medivation, Inc., The Leukemia and Lymphoma Society, Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT01096602

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 2010 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Institutes of Health (NIH), Medivation, Inc., The Leukemia and Lymphoma Society, Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myelogenous Leukemia, AML

Keywords

Dendritic Cell/AML vaccine, CT-011

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

DC AML Fusion Vaccine

Intervention Type

Biological

Intervention Name(s)

DC AML Vaccine

Intervention Description

Group 1: 2-3 doses of the vaccine at 4 week intervals

Primary Outcome Measure Information:

Title

Toxicity

Description

To assess the toxicity associated with treating AML patients with DC/AML fusion cells in the post-chemotherapy setting

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Immune Response

Description

To explore immunological response to DC/AML fusion vaccination in patients who have achieved a chemotherapy-induced remission.

Time Frame

2 years

Title

T-cell and Immune Response

Description

To correlate levels of circulating activated and regulatory T cells with immunologic response

Time Frame

2 years

Title

Disease Response

Description

To define anti-tumor effects by determining time to disease progression.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacalyn Rosenblatt, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33394722

Citation

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.

Results Reference

derived

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

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