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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07423104
Eligibility Criteria:
* Inclusion Criteria
* Participants with relapsed/refractory AML (according to European LeukemiaNet 2022 Criteria) after treatment with a Venetoclax-containing regimen.
* Participants with MDS, MPN, or MDS/MPN overlap who develop secondary AML after treatment with a Venetoclax-containing regimen.
* Prior therapy with hydroxyurea or emergency use of Cytarabine (up to 1 gm total dose) for cytoreduction is allowed.
* Prior hematopoietic stem-cell transplant (HSCT) and/or donor lymphocyte infusion (DLI) are allowed if at the time of relapse ≥ 90 days have passed from the date of the last stem cell transplant (90-day duration not required for DLI).
* Age ≥ 18 years old.
* Eastern Oncology Group (ECOG) performance status of ≤ 2
* Participants must agree to take the following reproductive precautions:
* Negative urine pregnancy test within one week prior to starting the study therapy for all women of childbearing potential.
* Participants who could become pregnant should use effective contraception during therapy and for 6 months after the last dose of study treatments. Participants with partners who could become pregnant should also use effective contraception during therapy and for 6 months after the last dose of study treatments.
* Nursing women should discontinue breastfeeding during therapy and for 10 days after the last dose of study treatments.
* Adequate organ function as follows:
* liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN). Unless liver enzyme abnormalities are suspected by the treating investigator to be due to leukemic infiltration after discussion with the principal investigator (PI).
* kidney function (creatinine \< 1.5 x ULN)
* Ability to understand the study procedures and requirements. A signed informed consent by the participant or an authorized legal representative is required.
* Exclusion Criteria
* Pregnant or breastfeeding women
* Uncontrolled active infections, i.e., signs of severe sepsis or hemodynamic instability
* Concurrent diagnosis with another active malignancy (indolent or adequately treated malignancies are allowed after discussion with the PI.
* Decompensated organ failure
* Documented hypersensitivity to any of the study treatments
* Participants with a diagnosis of acute promyelocytic leukemia (APL)
* Recipients of previous HSCT who have \> grade 1 graft versus host disease (GVHD) of the gastro-intestinal tract, liver, lung or skin.
* Prior therapy with purine analogues (Fludarabine, Clofarabine or Cladribine) unless it was part of a prior HSCT conditioning regimen.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07423104
Study Brief:
Protocol Section:
NCT07423104