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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT00056966
Eligibility Criteria:
Inclusion Criteria:
1. Patients with one of the following high risk diseases needing allogeneic hemopoietic stem cell transplantation:
Acute myeloid leukemia either a) Primary refractory, or b) Beyond first complete remission(CR1), or c) In CR1 with high risk of relapse
Acute lymphoblastic leukemia either a) Primary refractory, or b) Beyond first complete remission(CR1), or c) In CR1 with high risk of relapse
Chronic myeloid leukemia, either a) Accelerated phase, or b) Blast crisis, or c) Chronic phase and not achieving major cytogenetic response despite standard therapy
Chronic lymphocytic leukemia, either a) Primary refractory, or b) Beyond first complete remission(CR1),
Non Hodgkin's lymphoma, either a) Primary refractory, or b) Beyond first complete remission(CR1)
Hodgkin's disease, either a) Primary refractory, or b) Beyond first complete remission(CR1),
Myelodysplastic syndrome with IPSS score \> 0. (Appendix A)
Myeloproliferative disorders (with the exclusion of chronic myeloid leukemia) a) Primary Myelofibrosis with Lile score of 1 or 2 (Appendix B) b) Polycythemia Vera or Essential Thrombocythemia transformed to AML or Myelofibrosis and PV "spent phase"
Multiple Myeloma with stage II or III disease
Severe aplastic anemia
2. Conditions that increase Treatment Related Mortality (need one or more to be eligible):
Greater or equal to 35 years of age;
Ejection Fraction of less than 50%;
DLCO less than 50% or FEV1/FVC \< 80% of predicted value;
Diabetes Mellitus;
Renal insufficiency (serum creatinine abnormal);
Hepatic dysfunction-transaminases, or alkaline phosphatase, or bilirubin twice the upper limit of normal;
Prior recent history of systemic fungal infection;
Multiple prior treatment regimens (equal to or more than 3);
Significant Grade III or IV neurologic, cardiac, pulmonary, renal or hepatic toxicity from previous treatment;
Prior Autologous or Allogeneic Stem Cell transplantation;
3. Available Healthy Donor without any contraindications for donation. 5/6 or 6/6 related or unrelated donor (molecular typing for DRB1);
4. Patient and/or responsible person able to understand and sign consent
Exclusion Criteria:
Pregnant and lactating women, or women unwilling to use contraception.
HIV positive patient
Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)
Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)
Child's class C cirrhosis
Unstable cerebral vascular disease or recent hemorrhagic stroke (less than 6 months)
Patients with known allergy to rat serum products
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00056966
Study Brief:
Protocol Section:
NCT00056966