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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT01891968
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary signed informed consent before performance of any study-related procedure not part of normal medical care, indicating that that the patient is aware of the investigational nature of the study in keeping with the policies of MD Anderson Cancer Center (MDACC) and with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
2. Presence of phosphorylated p65 NF-kB component in at least 5% of bone marrow cells
3. Age \>/= 18 years of age at time of signing consent
4. Confirmed MDS by bone marrow biopsy according to World Health Organization (WHO) or French-American-British (FAB) criteria.
5. Classification by the International Prognostic Score System (IPSS) as low or intermediate-1 risk MDS according to cytogenetics, blood cytopenias and % bone marrow blasts within 28 days of the first dose of treatment in this study.
6. Patients must have received at least one prior therapy for MDS. Patients could have received transplant for MDS
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
8. Adequate liver function: Total bilirubin \</= 1.5 × the upper limit of normal (ULN), unless presence of Gilbert's Syndrome. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \</= 2.5 × ULN or \</= 5.0 ULN if hepatic involvement is present as determined by the investigator
9. Adequate renal function: Serum creatinine \</= 2 mg/dL or a calculated creatinine clearance of \>/= 50 mL/min (using the Cockcroft and Gault method).
10. Male patients, even if surgically sterilized (ie, status postvasectomy), who agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study treatment, or agree to completely abstain from heterosexual intercourse.
11. Female patients who are postmenopausal for at least 1 year before the Screening visit, or are surgically sterile, or if they are of childbearing potential, must have a negative pregnancy test within 72 hours of treatment start date and agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse
12. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria:
1. Significant medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study.
2. Any severe concurrent disease or condition (including active, uncontrolled systemic infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia) that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
3. Pregnant or lactating females.
4. Patient has \>/= Grade 2 peripheral neuropathy
5. Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
6. Patient has hypersensitivity to bortezomib, boron, or mannitol
7. Current diagnosis of another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
8. Treatment with other investigational agents, chemotherapy, or immunotherapy within 14 days of the start of this trial and throughout the duration of this trial.
9. Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01891968
Study Brief:
Protocol Section:
NCT01891968