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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT00923234
Eligibility Criteria:
Inclusion Criteria:
* Understand and voluntarily sign an informed consent form.
* Age \>=18 years at the time of signing the informed consent form.
* Able to adhere to the study visit schedule and other protocol requirements.
* Relapsed or refractory AML (\>30% blasts, FAB classification)with karyotype abnormalities involving monosomy 5 or del(5q) or MDS and t-MDS INT-2 or HIGH according to IPSS classification with karyotype abnormalities involving monosomy 5 or del(5q) either previously treated or untreated
* Not eligible for an immediate allogeneic HSCT (due to donor unavailability)
* All previous MDS or AML specific therapy with exception of corticosteroids not exceeding doses of 10mg/day prednisone must have been discontinued at least 1 week prior to study enrollment.
* Non-hematological toxicity (except alopecia) resulting from previous treatment must be resolved to WHO CTC Grade ≤ 2.
* ECOG performance status of \< 3 at study entry.
* Laboratory test results within these ranges:Serum creatinine \<= 2.0 mg/dL, Total bilirubin \<= 3 x ULN, AST (SGOT) and ALT (SGPT) \<= 3 x ULN
* Females of childbearing potential must agree to use a reliable form of contraception or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.
Exclusion Criteria:
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Pregnant or breast feeding females. (Lactating females must agree not to breast feed while on study).
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Known hypersensitivity to thalidomide, lenalidomide, 5-azacitidine or mannitol.
* Myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias.
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Uncontrolled lung disease.
* Known positive for HIV or acute infectious hepatitis, type A, B or C.
* Participation in another clinical study in the 4 weeks prior to enrollment or during this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00923234
Study Brief:
Protocol Section:
NCT00923234