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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT00304018
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following advanced hematologic malignancies:
* Acute myeloid leukemia (AML) meeting the following criteria:
* Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:
* High-risk cytogenetics (-7, -7q, -5, -5q, t\[6,9\], t\[9,11\], complex, Philadelphia chromosome positive \[Ph+\])
* AML evolved from prior myelodysplasia
* AML secondary to prior chemotherapy
* Failed to achieve remission
* In second or subsequent remission
* Marrow blasts ≤ 10% (may be achieved using chemotherapy)
* Myelodysplastic syndromes (MDS) with high-risk features
* International Prognostic Scoring System (IPSS) score intermediate -2 or high-risk
* Marrow blasts ≤ 20% (may be achieved using chemotherapy)
* Acute lymphoblastic leukemia meeting the following criteria:
* Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:
* High-risk cytogenetics (Ph+, t\[4,11\], 11q23 abnormalities, and monosomy 7)
* Required \> 1 induction course to achieve remission
* Failed to achieve remission
* In second or subsequent remission
* Marrow blasts ≤ 10% (may be achieved using chemotherapy)
* Chronic myelogenous leukemia meeting ≥ 1 of the following criteria:
* Accelerated phase
* Chronic phase refractory to imatinib mesylate
* Blastic phase
* Marrow blasts ≤ 10% (may be achieved using chemotherapy)
* Multiple myeloma meeting 1 of the following criteria:
* Stage II or III disease with \> first relapse or refractory disease
* Newly diagnosed disease with chromosome 13 abnormalities
* Lymphoma meeting the following criteria:
* One of the following subtypes:
* Diffuse large cell lymphoma
* Mantle cell lymphoma
* Peripheral T-cell lymphoma
* T-natural killer (NK) cell lymphoma
* Hodgkin's lymphoma
* Disease failed to respond to primary therapy, progressed, or recurred after prior therapy
* Patients who have failed autologous stem cell transplantation are eligible provided it has been \> 1 year since transplant
* No rapid progression of malignant disease
* Not eligible for autologous stem cell transplantation
* Available umbilical cord blood (1-3 units) donor matching at ≥ 4 of 6 HLA antigens (A, B, and DR)
* Patients with an HLA-identical or 1 antigen-mismatched related donor OR a potential HLA-matched unrelated donor matching at \> 6/8 (A, B, C, DR) alleles are not eligible
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Creatinine \< 2.0 mg/dL
* Creatinine clearance \> 40 mL/min
* Bilirubin \< 2.0 mg/dL
* AST and alkaline phosphatase \< 3 times upper limit of normal
* Hepatitis C and active hepatitis B allowed if patient has ≤ grade 2 inflammation or fibrosis by liver biopsy
* Ejection fraction \> 40% by echocardiogram or MUGA
* DLCO \> 40% of predicted
* Not pregnant or nursing
* Negative pregnancy test
* No known HIV infection
* No active infection requiring ongoing antibiotic treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00304018
Study Brief:
Protocol Section:
NCT00304018