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 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT00469859
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of acute myeloid leukemia (AML) according to FAB classification
* At least 5% blasts in the bone marrow, with or without extramedullary disease
* In first relapse after induction therapy OR refractory to induction therapy with ≤ 1 attempt at remission induction
* Patients who are in a first relapse \> 1 year from their initial diagnosis of AML are excluded from the dose-finding phase of the study, but are eligible for the efficacy phase
* First relapse after hematopoietic stem cell transplantation (HSCT) allowed provided patient has no evidence of active graft-versus-host disease (GVHD) and is at least 4 months posttransplantation
* Positive for a FLT3 activating mutation (internal tandem duplication or kinase domain point mutation) using standard polymerase chain reaction-based procedures at any time in the course of illness
* Treatment-related AML allowed
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 50-100% (\> 16 years of age) OR Lansky PS 50-100% (≤ 16 years of age)
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age and gender as follows:
* Creatinine no greater than 0.4 mg/dL (1 month to \< 6 months of age)
* Creatinine no greater than 0.5 mg/dL (6 months to \< 1 year of age)
* Creatinine no greater than 0.6 mg/dL (1 year to \< 2 years of age)
* Creatinine no greater than 0.8 mg/dL (2 years to \< 6 years of age)
* Creatinine no greater than 1 mg/dL (6 years to \< 10 years of age)
* Creatinine no greater than 1.2 mg/dL (10 years to \< 13 years of age)
* Creatinine no greater than 1.4 mg/dL (females) or 1.5 mg/dL (males) (13 years to \< 16 years of age)
* Creatinine no greater than 1.4 mg/dL (females) or 1.7 mg/dL (males) (16 years of age and over)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT \< 5 times ULN (unless it is related to leukemic involvement)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
PRIOR CONCURRENT THERAPY:
* Recovered from all prior therapy
* No prior cumulative anthracycline doses exceeding 450 mg/m\^2 daunorubicin equivalents
* Patients who relapse after receiving treatment on protocol COG-AAML03P1 or COG-AAML0531 (300 mg/m\^2 of daunorubicin hydrochloride and 48 mg/m\^2 of mitoxantrone hydrochloride) allowed provided they have not received any additional anthracyclines
* At least 14 days since prior cytotoxic therapy
* Hydroxyurea allowed to decrease the WBC prior to starting protocol treatment
* No concurrent hydroxyurea
* At least 7 days since prior biologic agents
* At least 14 days since prior monoclonal antibody therapy
* Radiotherapy to chloromas allowed
* Irradiated lesion may not be used to assess tumor response
* No other concurrent chemotherapy, investigational therapy, immunomodulating agents, or steroids
* Steroids used as an antiemetic allowed
* Prophylactic intrathecal cytarabine allowed
* No concurrent CYP3A4,5 inhibitors, including any of the following:
* Azole antifungals (e.g., fluconazole or voriconazole)
* Cyclosporine
* Erythromycin
* Clarithromycin
* Troleandomycin
* HIV protease inhibitors
* Nefazodone
* No concurrent CYP3A4,5 inducers, including any of the following:
* Carbamazepine
* Dexamethasone
* Rifampin
* Phenobarbital
* Phenytoin
* Hypericum perforatum (St. John's wort)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
30 Years
Study:
NCT00469859
Study Brief:
Protocol Section:
NCT00469859