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 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT03826992
Eligibility Criteria:
Inclusion Criteria:
* Ages 1 Year to 39 Years
* Diagnosis of one of the following:
* Acute myeloid leukemia (AML), any subtype except
* Patients with acute promyelocytic leukemia (APML) are NOT eligible
* Patients with ML-DS are NOT eligible
* Myeloid sarcoma
* Acute leukemia of ambiguous lineage (ALAL)
* Acute undifferentiated leukemia (AUL)
* T/myeloid mixed phenotype acute leukemia (MPAL)
* B/myeloid MPAL
* MPAL with KMT2A-rearrangement MPAL with t (9;22) are NOT eligible
* T-cell acute lymphoblastic leukemia (T ALL)
* Early thymocyte precursor (ETP) ALL
* KMT2A-rearranged ALL
* Disease Status
* Relapsed/Refractory AML, MPA, and AUL
* Untreated therapy related AML
* Relapsed/Refractory KMT2A-rearranged ALL, T-cell ALL, ETEP ALL
* Karnofsky/Lanksy performance level score of greater than or equal to 50 percent.
* Prior therapy requirements
* Fully recovered from acute toxicities of Hematopoietic Stem Cell Transplant (HSCT) or Anthracycline Exposure
* 14 days must have elapsed since the completion of systemic cytotoxic therapy other than hydroxyurea, decitabine or azacitidine
* 2 weeks must have elapsed for local palliative radiotherapy (RT); 6 months must have elapsed if prior craniospinal RT or if 50% radiation of pelvis, and at least 6 weeks must have elapsed if other substantial bone marrow radiation
* Adequate renal, liver, cardiac, and central nervous system (CNS) function
Exclusion Criteria:
* Diagnosis of one of the following:
* Myeloid Leukemia associated with Down Syndrome (ML-DS)
* Acute Promyelocytic Leukemia (APML)
* Acute leukemia with CNS status 3 involvement
* Philadelphia chromosome t(9;22) positive leukemia (Ph+ ALL, AML, MPAL, or AUL)
* Fanconi Anemia, Shwachman-Diamond syndrome, or any other bone marrow failure syndrome or DNA repair disorder
* Wilson's Disease or other copper-metabolism disorder
* Pregnant or breastfeeding
* Uncontrolled infection
* Received greater than 13.6 Gray (Gy) prior radiation to the mediastinum
* Receipt of growth factors within 7 days prior to enrollment
* Currently receiving another investigational drug
* Currently receiving anti-cancer agents (with the exception of intrathecal (IT) agents or hydroxyurea)
* Unable to comply with the safety monitoring requirements of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
39 Years
Study:
NCT03826992
Study Brief:
Protocol Section:
NCT03826992