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 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT00045435
Eligibility Criteria:
Inclusion Criteria:
* Patients with de novo AML (French-American-British \[FAB\] MO-M2, M4-M7) or secondary AML who achieve CR1 after induction chemotherapy and one or two cycles of consolidation chemotherapy
* Transplant conditioning must occur within 6 months of diagnosis
* Patient enrollment must be approved by the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator (PI) or the PI's designee
* DONOR: Related donor who is genotypically or phenotypically identical
* DONOR: Age \>= 12 years
* DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis
* DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian)
Exclusion Criteria:
* AML FAB M3
* AML involvement of the central nervous system (CNS) as defined by a positive cytospin of cerebral spinal fluid at the time of enrollment
* Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology
* Human immunodeficiency virus (HIV) seropositivity
* Fungal infections with radiographic progression after receipt of amphotericin B or active triazole for greater than one month
* Diffusion capacity of carbon monoxide (DLCO) corrected \< 40%
* Total lung capacity (TLC) \< 40%
* Forced expiratory volume in one second (FEV1) \< 40% or requiring supplementary oxygen
* The FHCRC principal investigator of the study must approve enrollment of all patients with pulmonary nodules
* Cardiac ejection fraction \< 40%
* Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, bridging fibrosis, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3mg/dL, or symptomatic biliary disease
* Karnofsky Performance Score \< 70
* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
* Females who are pregnant or breastfeeding
* No intensive chemotherapy can be given within three weeks (or the interval in which a cycle of standard chemotherapy would be administered in a non-transplant setting) prior to initiating the nonmyeloablative transplant conditioning
* Patients with active non-hematologic malignancies (except non-melanoma skin cancers)
* Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a \> 20% risk of disease recurrence
* Patients with active bacterial or fungal infections unresponsive to medical therapy
* DONOR: Identical twin
* DONOR: Pregnancy
* DONOR: HIV seropositivity
* DONOR: Inability to achieve adequate venous access
* DONOR: Known allergy to G-CSF
* DONOR: Current serious systemic illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT00045435
Study Brief:
Protocol Section:
NCT00045435