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

NCT01096602 | Completed Phase 2 DMC

• 1 other identifier: 09-412
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myelogenous Leukemia; AML

Keywords

Dendritic Cell/AML vaccine; CT-011

Outcome Measures

Primary Outcomes (1)

• Toxicity

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

  2 years

Secondary Outcomes (3)

• Immune Response

  2 years

• T-cell and Immune Response

  2 years

• Disease Response

  2 years

Study Arms (1)

Group 1

EXPERIMENTAL

DC AML Fusion Vaccine

Biological: DC AML Vaccine

Interventions

DC AML Vaccine BIOLOGICAL

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening:
• Patients with AML at initial diagnosis or at first relapse
• 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

You may not qualify if:

• Screening:
• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institutes of Health (NIH): collaborator
• Medivation, Inc.: collaborator
• The Leukemia and Lymphoma Society: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 33394722 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jacalyn Rosenblatt, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 31, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

US (1)