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 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT00623935
Eligibility Criteria:
Inclusion Criteria:
For Study Registration:
* Age 55 - 70 years.
* Subjects diagnosed with AML (\> 20% myeloblasts).
For Proceeding to Transplant:
* Subjects must be in either complete remission (CR) or partial remission (PR) within 14 days prior to admission.
* Subjects must be \> 21 days since completion of prior systemic chemotherapy or radiation therapy (including craniospinal XRT), prior to admission .
* Organ function requirements for a reduced intensity (FluBu2) regimen (must be met within 21 days of admission):
* Cardiac: LV Ejection Fraction \> 40% on MUGA or Echocardiogram.
* Pulmonary: FEV1 and FVC \> 40% predicted, DLCO \> 40% of predicted.
* Renal: Serum creatinine \< 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH).
* Hepatic: serum total bilirubin \< 3.0 mg/dl and AST / ALT \< 4x ULN
* Karnofsky \> 60%.
* Organ function requirements for a full intensity (FluBu4) regimen (must be met within 21 days of admission):
* Cardiac: LV Ejection Fraction \> 40% on MUGA or Echocardiogram.
* Pulmonary: FEV1 and FVC \> 50% predicted, DLCO (corrected for hemoglobin) \> 50% of predicted.
* Renal: serum creatinine \< 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH)
* Hepatic: serum total bilirubin \< 3.0 mg/dl and AST / ALT \< 4x ULN.
* Karnofsky \> 60%.
Exclusion Criteria:
For Study Registration:
* Subjects with M3 AML (FAB classification)
For Proceeding to Transplant:
* Subjects who exhibit signs of progressive disease (\> 20% blasts) within 14 days prior to admission for transplant
* Patients with an uncontrolled viral or fungal infection within the prior 28 days.
* Patients who are HIV1 or HIV2 positive.
* Uncontrollable medical or psychiatric disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT00623935
Study Brief:
Protocol Section:
NCT00623935