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:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
NCT ID:
NCT00048412
Eligibility Criteria:
Inclusion criteria
1. Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia and Hodgkins Disease) or Renal Cell Carcinoma.
2. Conditions that increase treatment related mortality (need one or more to be eligible):
1. Greater to or equal to 50 years of age.
2. EF of less than 45%
3. DLCO less than 50% of FEV1 50-75% of predicted value.
4. Diabetes Mellitus
5. Renal Insufficiency (but creatine clearance not less than 25ml/min).
6. Prior recent history of systemic fungal infection.
7. 3rd or greater remission of AML or ALL
8. More than 1 year of diagnosis (CML or Myeloma patients)
9. Multiple types of treatment regimens. (equal to or more than 3)
10. Prior autologous or allogeneic stem cell transplantation.
11. Significant grade III or IV neurologic or hepatic toxicity from previous treatment.
12. No matched sibling donor.
3. Available healthy donor without any contraindications for donation. 5/6 or 6/6 related donor. 5/6 or 6/6 unrelated donor (molecular typing for DRB1)
4. Patient and/or responsible person able to understand consent.
5. Age between birth and 70 years.
6. For women of childbearing potential, negative pregnancy test.
Exclusion criteria
1. Patient is pregnant, lactating or unwilling to use contraceptives
2. HIV positive patient
3. Uncontrolled intercurrent infection
4. Refractory AML, or ALL
5. Untreated Blast Crisis for CML
6. Uncontrolled High-grade lymphoproliferative disease/lymphoma.
7. Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)
8. Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)
9. Hemodialysis dependent
10. Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x normal.
11. Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months)
12. Active CNS disease from hematological disorder.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
70 Years
Study:
NCT00048412
Study Brief:
Protocol Section:
NCT00048412