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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT01451268
Eligibility Criteria:
Inclusion Criteria:
* AML (except acute promyelocytic leukemia, AML M3) with high-risk features defined as one or more of the following criteria:
* refractory to or relapsed after at least one cycle of standard chemotherapy
* \> 10% bone marrow blasts at day 15 of the first induction cycle
* adverse risk cytogenetics including complex karyotype (≥ 3 abnormalities or abnormalities of chromosomes 3, 5 or 7) regardless of stage
* secondary to MDS or radio-/chemotherapy or
* MDS RAEB according to the WHO classification or intermediate-2 or high-risk according to IPSS or
* Chronic myelomonocytic leukemia (CMML) with ≥ 5% bone marrow blasts and
* Allogeneic HSCT with reduced intensity conditioning (see Section 15.1 for definition) performed within 60 - 150 days prior to study entry
* Complete hematologic remission documented by bone marrow aspiration within 28 days prior to study entry
Exclusion Criteria:
* Active acute GvHD overall grade 2 - 4
* Prior treatment with a deacetylase (DAC) inhibitor
* Patients with impaired cardiac function or other concurrent severe and/or uncontrolled medical conditions
* Clinical symptoms suggesting central nervous system (CNS) leukemia
* Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01451268
Study Brief:
Protocol Section:
NCT01451268