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 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT00387959
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* CD20+\* aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following:
* Diffuse large cell (DLC) NHL meeting 1 of the following criteria:
* Relapsed disease after initial therapy but failed to mobilize or had bone marrow involvement and therefore is not suitable for an autologous stem cell transplantation
* High-intermediate or high-risk, second-line, age-adjusted International Prognostic Index (IPI) score and in second complete remission (CR) or partial remission (PR) after prior autologous stem cell transplantation
* Failed prior autologous stem cell transplantation and in at least PR after salvage chemotherapy
* Large cell transformation of indolent NHL/chronic lymphocytic leukemia (CLL) meeting the following criteria:
* CR/PR of the large cell component of disease after salvage chemotherapy or autologous stem cell transplantation
* Mantle cell lymphoma meeting 1 of the following criteria:
* High-risk, as defined by p53 positivity and in first CR/PR after initial therapy
* Relapsed disease after initial therapy and in second or third CR/PR after salvage chemotherapy
* CD20+\* indolent NHL or CLL meeting the following criteria:
* Must be in second or subsequent progression (pre-allograft cytoreduction necessary but CR/PR not required)
* Indolent NHL includes, but is not limited to, any of the following:
* Follicular NHL
* Small cell NHL
* Marginal zone NHL NOTE: \*CD20 positivity must be demonstrated within the past 12 months
* Relapsed disease must be biopsy proven
* Prior pre-allograft cytoreduction may have included 1 of the following:
* Single autologous stem cell transplantation with high-dose chemotherapy conditioning, if appropriate, and no conditioning prior to transplantation
* Two or more courses of intensive combination chemotherapy (e.g., rituximab, irinotecan hydrochloride, cetuximab, epirubicin hydrochloride \[RICE\]) as appropriate according to diagnosis and prior therapy
* Heavily pre-treated CLL patients in whom further combination chemotherapy is not appropriate may receive single-agent intermediate-dose cyclophosphamide for 2-3 courses
* No mantle cell or DLC NHL with progressive disease at allograft work-up
* No suitable matched related or unrelated donor available
* Two umbilical cord blood (UCB) units available meeting the following criteria:
* Units and recipient must be ≥ 4/6 HLA-A and -B antigen and DRB1 allele matched
* Each unit must have ≥ 1.5 x 10\^7 total nucleated cells/recipient body weight
PATIENT CHARACTERISTICS:
* Karnofsky performance score 70-100%
* Creatinine clearance ≥ 50 mL/min
* Bilirubin \< 2.5 mg/dL
* AST and ALT ≤ 3 times upper limit of normal (unless due to benign congenital hyperbilirubinemia)
* Spirometry and corrected DLCO ≥ 50% normal
* LVEF ≥ 40%
* Albumin ≥ 2.5 g/dL
* No active and uncontrolled infection at time of transplantation, including active infection with Aspergillus or other mold
* No HIV positivity
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No more than 120 days since prior autologous stem cell transplantation
* No more than 60 days since prior chemotherapy
* No prior allogeneic transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00387959
Study Brief:
Protocol Section:
NCT00387959