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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00299767
Eligibility Criteria:
Inclusion Criteria:
* Disease Status: NHL, HD, or MM refractory to chemotherapy or relapsed; CLL Rai Stage III/IV, or lymphocyte doubling time of 6 months, or Stage I/II resistant to 2 chemotherapy regimens; AML or ALL in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder
* Estimated disease-free survival of less than one year
* ECOG performance status of 0, 1, 2
* Lack of 6/6 or 5/6 HLA matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant
* 4/6 or greater HLA A, B, CRB1 cord blood units with a combined nucleated cell dose from of \> 3.7 x 10(7) NC/kg
Exclusion Criteria:
* Cardiac disease: symptomatic congestive hearth failure or RVG or echocardiogram determined left ventricular ejection fraction of \< 45%, active angina pectoris, or uncontrolled hypertension
* Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of \< 50%
* Renal disease: serum creatinine \> 2.0 mg/dl
* Hepatic disease: serum bilirubin \> 2.0 mg/dl (except in the case of Gilbert's syndrome), SGPT or SGOT \> 3 x normal
* Neurologic disease: symptomatic leukoencephalopathy, active DNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
* HIV antibody or Hepatitis B surface antigen positivity
* Uncontrolled infection
* Pregnancy or breast-feeding mother
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
65 Years
Study:
NCT00299767
Study Brief:
Protocol Section:
NCT00299767