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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT00775593
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:
* At least 20% of blasts in the bone marrow
* AML in first relapse OR refractory to no more than one prior combination of intensive chemotherapy induction regimen
* No acute promyelocytic leukemia
* No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
* No active CNS leukemia
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Life expectancy ≥ 4 weeks
* Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)\*
* AST and ALT ≤ 2.5 times ULN\*
* Serum creatinine ≤ 1.0 mg/dL\* OR estimated glomerular filtration rate \> 60 mL/min
* No active uncontrolled systemic infection
* No concurrent active malignancy
* No HIV positivity
* No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: \*Unless due to organ leukemic involvement
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 2 weeks since prior myelosuppressive chemotherapy
* At least 48 hours since prior hydroxyurea
* No prior clofarabine or temsirolimus
* No prior allogeneic stem cell transplantation
* No investigational drug within the past 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00775593
Study Brief:
Protocol Section:
NCT00775593