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

Status: Recruiting
Phase: Phase 2
Diagnosis: Leukemia/MDS
NCT ID: NCT01096602 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-412

 

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) alone, as well as of the combination of CT-011, after participants have achieved a remission with chemotherapy. In this clinical trial, patients are treated with a tumor vaccine alone or in combination with CT-O11, an investigational monoclonal antibody that may augment response to vaccination. Monoclonal antibodies are known to target specific cells (in this case, cells in the immune system). This immunotherapy may help to control leukemic cells that are resistant to chemotherapy and prevent disease recurrence. 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 the combination of DC AML vaccine and CT-011 will prevent or delay the disease from coming back.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute

Overall PI:
Jacalyn Rosenblatt, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:
Richard Stone, MD, Dana-Farber Cancer Institute

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

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
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