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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT06811233
Eligibility Criteria:
Inclusion Criteria:
1. Understand and voluntarily sign an informed consent form for participants 18 years or older, unless LAR signs where applicable along with any required verbal assents if patients can provide assent.
2. Age 18 years or older at the time of signing the informed consent form.
3. Diagnosis of Any of the Following:
* Newly diagnosed (or untreated) AML or Newly diagnosed Myeloproliferative Neoplasm in Myeloid Blast Phase (MPN-BP) \[including Chronic Myeloid Leukemia in Blast Phase (CML-BP)\], Ph+AML with intermediate-risk or high-risk (by ELN), or any other intermediate or high-risk AML by ELN
* Secondary AML regardless of ELN risk status, however, may not have CBF \[t(8;21) or inv(16)\]
Secondary AML types include:
* Secondary AML evolved from prior untreated MDS, myeloproliferative neoplasm (MPN), or Aplastic Anemia
* Therapy-related AML (t-AML)
* AML evolved after prior MDS, MPN, or Aplastic Anemia after prior therapy for those myeloid bone marrow disorders
* Secondary AML, including blast phase of MPN (MPN-BP) \[also, including CML in blast phase (BP of CML) after prior hematologic myeloid bone marrow disease (MDS, MPN, Aplastic Anemia, CML) (patients may have received treatment for their prior hematologic disorder for their previous bone marrow disorder) . Newly diagnosed (or untreated) myeloid blast phase of MPN (including myeloid blast phase of CML)/Ph+AML.150
4. Patients can enroll on this study after start of non-investigational induction therapy but must be within first 2 cycles of front-line therapy, as long as not in a complete remission.
5. Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid-Blast Phase of MPN and Myeloid Blast Phase of Chronic Myeloid Leukemia (CML) are allowed/Ph+ AML are allowed.
6. Eastern Cooperative Oncology Group (ECOG) performance status of . 2
7. Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy):
* Serum creatinine.2.0 mg/dL
* Total Bilirubin . 2.0 x Upper limit of normal (ULN) unless the patient has Gilbert fs.
* AST (SGOT) and/or ALT (SGPT) . 2.0 x ULN
8. Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy test within 14 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partners vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of childbearing potential.
9. Extramedullary disease is allowed if it can be measured and followed for response.
Exclusion Criteria:
1. Nursing and pregnant individuals. Should a study participant become pregnant or suspect pregnancy while participating in this study, the study participant should inform their treating physician immediately.
2. Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk.
3. Acute Promyelocytic leukemia (APL)
4. Prior venetoclax failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06811233
Study Brief:
Protocol Section:
NCT06811233