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:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT02992860
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years of age
* Diagnosis of AML or MDS
* At least ≥ 5% BM blasts at the time of screening (done by central morphology)
* At least one cytopenia (ANC \< 1800/μL or platelet count \< 100,000/μL or hemoglobin \< 10 g/dL)
* Failure to achieve complete or partial response or hematological improvement after at least six (azacitidine) or four (decitabine) 4-week treatment cycles administered during the past two years OR
* Relapse after initial complete or partial response or hematological improvement observed after at least six (azacitidine) or four (decitabine) 4-week treatment cycles administered during the past two years OR
* Intolerance to treatment with HMA (hypomethylating agents) defined by drug-related ≥ Grade 3 liver or renal toxicity leading to treatment discontinuation during the past two years
* Failed to respond to, relapsed following, not eligible, or opted not to participate in bone marrow transplantation
* Off all other treatments for AML/MDS for at least four weeks; Filgrastim (G-CSF) and erythropoietin are allowed before and during the study as clinically indicated
* No medical need for or patient opted not to receive induction chemotherapy
* ECOG performance status of 0-2
* Willing to adhere to the prohibitions and restrictions specified in the protocol
* Signed informed consent
Exclusion Criteria:
* Previous treatment with a CD123 agent or T- or NK cell redirecting therapy
* Patients having received intensive chemotherapy to treat HMA failure
* Diagnosis of acute promyelocytic leukemia (APL)
* WBC \> 15 GPT/L
* Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* Active infection not adequately responding to appropriate therapy
* Total bilirubin \> 1.5 mg/dL not related to hemolysis or Gilbert's disease
* ALT/AST \> 2.5 x upper limit of normal
* Serum creatinine \> 2.0 mg/dL
* Patients who are unwilling to follow highly effective contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives, contraceptive injections, intrauterine device, , contraceptive patch, surgical sterilization or true sexual abstinence) before entry, at least at screening, throughout the study and within 3 months after last study drug administration
* Female patients with reproductive potential who do not have a negative urine β-HCG pregnancy test at screening and prior to the first study drug administration at visit 1 (day 0) of JNJ-56022473 treatment period.
* Female patients who are lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02992860
Study Brief:
Protocol Section:
NCT02992860