ACTIVE_NOT_RECRUITING

Dendritic Cell/AML Fusion Cell Vaccine Following Allogeneic Transplantation in AML Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML). The interventions involved in this study are: * Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) * Decitabine, a chemotherapy drug

Official Title

A Phase I Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Alone and in Conjunction With Decitabine Following Allogeneic Transplantation in AML Patients

Quick Facts

Study Start:2018-10-11

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03679650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with AML who have undergone AML cell harvest and cryopreservation as per protocol 16-593 or companion protocol 18-232. * Patients must have had a minimum of 5x107 cells cryopreserved. * Patients must be day 25-45 following allogeneic transplantation from either: * Group A: HLA 8/8 or 7/8 matched related donor or HLA 8/8 matched unrelated donor, as determined by antigen or allele level typing at HLA A,B,C, and HLA DRB1. * Group B: Haplo-identical donor * Patients must be ≥ 18 years old * ECOG performance status ≤2 (Appendix A) * Participants must have normal organ and marrow function as defined below: * Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease) * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal * Creatinine ≤ 2.0 mg/dl * Absolute neutrophil count \> 1000 * Platelet count \> 50,000 * The effects of DC/AML fusion cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * No evidence of ongoing grade 2 or higher aGVHD * Must be on prednisone \<20mg or other steroid equivalent * Donor chimerism of bone marrow \>60% * Resolution of all transplant related grade III-IV toxicity as per CTC criteria 4.0 * Complete remission defined by absence of circulating blasts and less than 5% blasts in the bone marrow * Ability to understand and the willingness to sign a written informed consent document. * Assessments to be done between Day 45-75 post-transplant. * At least 2 doses of fusion vaccine were produced * No ongoing grade II-IV acute GVHD * Prednisone requirement of \< 20mg a day or steroid equivalent * Participants must have normal organ and marrow function as defined below: * Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease) * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal * Creatinine ≤ 2.0 mg/dl * Absolute neutrophil count \> 1000 * Platelet count \> 50,000 * No uncontrolled acute infection * No CTCAE grade ≥ 3 non-hematologic toxicity * No serious intercurrent illness such as active acute infection, or significant cardiac disease characterized by clinically significant arrhythmia, active ischemic coronary disease or symptomatic congestive heart failure. * Participants must be in a complete remission * Assessments to be done within 3 days prior to initiation of therapy. * Participants must have normal organ and marrow function as defined below: * Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease) * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal * Creatinine ≤ 2.0 mg/dl * Absolute neutrophil count \> 1000 * Platelet count \> 50,000	* Because of compromised cellular immunity, patients with a known history of HIV are excluded * Leukemia with active CNS involvement * Patients must not be pregnant. All premenopausal patients will undergo pregnancy testing. Men will agree to not father a child while on protocol treatment. Men and women will practice effective birth control while receiving protocol treatment. * Participants may not be receiving any other Non-FDA approved study agents at the start of vaccination * Uncontrolled intercurrent illness including uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements. * Autoimmune or inflammatory disorders requiring active treatment with systemic steroids or immunosuppressive therapy limited to the following: * GI Disorders: (including inflammatory bowel disease \[e.g., ulcerative colitis, Crohn's disease\] * Systemic lupus erythematosus * Wegener's syndrome \[granulomatosis with polyangiitis\] * Myasthenia gravis * Graves' disease * Rheumatoid arthritis * Hypophysitis * Uveitis

Inclusion Criteria

Exclusion Criteria

* Patients with AML who have undergone AML cell harvest and cryopreservation as per protocol 16-593 or companion protocol 18-232.
* Patients must have had a minimum of 5x107 cells cryopreserved.
* Patients must be day 25-45 following allogeneic transplantation from either:
* Group A: HLA 8/8 or 7/8 matched related donor or HLA 8/8 matched unrelated donor, as determined by antigen or allele level typing at HLA A,B,C, and HLA DRB1.
* Group B: Haplo-identical donor
* Patients must be ≥ 18 years old
* ECOG performance status ≤2 (Appendix A)
* Participants must have normal organ and marrow function as defined below:
* Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
* AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
* Creatinine ≤ 2.0 mg/dl
* Absolute neutrophil count \> 1000
* Platelet count \> 50,000
* The effects of DC/AML fusion cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* No evidence of ongoing grade 2 or higher aGVHD
* Must be on prednisone \<20mg or other steroid equivalent
* Donor chimerism of bone marrow \>60%
* Resolution of all transplant related grade III-IV toxicity as per CTC criteria 4.0
* Complete remission defined by absence of circulating blasts and less than 5% blasts in the bone marrow
* Ability to understand and the willingness to sign a written informed consent document.
* Assessments to be done between Day 45-75 post-transplant.
* At least 2 doses of fusion vaccine were produced
* No ongoing grade II-IV acute GVHD
* Prednisone requirement of \< 20mg a day or steroid equivalent
* Participants must have normal organ and marrow function as defined below:
* Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
* AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
* Creatinine ≤ 2.0 mg/dl
* Absolute neutrophil count \> 1000
* Platelet count \> 50,000
* No uncontrolled acute infection
* No CTCAE grade ≥ 3 non-hematologic toxicity
* No serious intercurrent illness such as active acute infection, or significant cardiac disease characterized by clinically significant arrhythmia, active ischemic coronary disease or symptomatic congestive heart failure.
* Participants must be in a complete remission
* Assessments to be done within 3 days prior to initiation of therapy.
* Participants must have normal organ and marrow function as defined below:
* Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
* AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
* Creatinine ≤ 2.0 mg/dl
* Absolute neutrophil count \> 1000
* Platelet count \> 50,000

* Because of compromised cellular immunity, patients with a known history of HIV are excluded
* Leukemia with active CNS involvement
* Patients must not be pregnant. All premenopausal patients will undergo pregnancy testing. Men will agree to not father a child while on protocol treatment. Men and women will practice effective birth control while receiving protocol treatment.
* Participants may not be receiving any other Non-FDA approved study agents at the start of vaccination
* Uncontrolled intercurrent illness including uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
* Autoimmune or inflammatory disorders requiring active treatment with systemic steroids or immunosuppressive therapy limited to the following:
* GI Disorders: (including inflammatory bowel disease \[e.g., ulcerative colitis, Crohn's disease\]
* Systemic lupus erythematosus
* Wegener's syndrome \[granulomatosis with polyangiitis\]
* Myasthenia gravis
* Graves' disease
* Rheumatoid arthritis
* Hypophysitis
* Uveitis

Contacts and Locations

Principal Investigator

Jacalyn Rosenblatt, MD

PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Jacalyn Rosenblatt, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-11

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2018-10-11

Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Acute Myelogenous Leukemia