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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT00238433
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Intermediate- or high-grade non-Hodgkin's lymphoma (NHL), meeting 1 of the following criteria:
* In first complete remission (CR) AND at high-risk for relapse, as defined by all of the following criteria:
* High age-adjusted International Prognostic Index category AND meets the following criteria at diagnosis:
* Stage III or IV disease
* Lactic dehydrogenase abnormal
* Eastern Cooperative Oncology Group (ECOG) score 0-2
* Mantle cell histology
* Primary refractory disease
* Beyond first CR
* Low-grade NHL
* Beyond second relapse
* Hodgkin's lymphoma
* Primary refractory disease OR beyond first CR
* Must have an adequate number of stored autologous peripheral blood stem cells (PBSCs) (i.e., 2.0 x 10\^6 hematopoietic progenitor cell antigen (CD34)-positive cells/kg)
* Patients who are not able to mobilize a sufficient number of PBSCs may use bone marrow instead
* No active CNS disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
* 0 to 70
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin \< 2 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times ULN
Renal
* Creatinine ≤ 2.0 mg/dL
* Creatinine clearance ≥ 50 mL/min
Pulmonary
* No significant pulmonary dysfunction, defined as Diffusing Capacity the Lung for Carbon monoxide (DLCO) \< 60% of predicted
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for ≥ 2 months before and during study participation
* HIV negative
* No significant active infection that would preclude PBSC transplantation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior transplantation
* No other concurrent blood products during PBSC transplantation
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* More than 60 days since prior local or regional radiotherapy
Surgery
* Not specified
Other
* More than 30 days since prior investigational drugs
* No concurrent amphotericin
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
70 Years
Study:
NCT00238433
Study Brief:
Protocol Section:
NCT00238433