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

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Sep 17, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating a new cancer vaccine called the Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) to see if it can help patients with Acute Myelogenous Leukemia (AML) after they have undergone a stem cell transplant. The study is currently recruiting participants aged 18 and older who have previously had their AML cells collected and frozen. To join, patients need to be between 25 to 45 days post-transplant and must meet specific health criteria, such as normal blood counts and no active infections.

Participants in the trial will receive the DC/AML vaccine along with a chemotherapy drug called Decitabine. Before starting the treatment, there will be a series of health assessments to ensure it is safe for them to participate. It's important for participants to understand that they need to practice effective birth control during the study, as the effects of the vaccine on pregnancy are not known. Overall, this trial aims to explore a new way to treat AML and improve outcomes for patients who have undergone a transplant.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• • OR
• • 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.
• • Eligibility Prior to Initiating Vaccination (Groups A and B)
• • 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
• • Pre-Treatment Criteria Prior to Decitabine (Group A Cohort 2)
• • 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
• Exclusion Criteria:
• • 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