Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT03679650
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03679650
Study Brief:
Protocol Section:
NCT03679650