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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT00006695
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of non-Hodgkin's lymphoma (NHL) of one of the following types:
* Diffuse large B-cell
* Composite (at least 50% of tumor showing diffuse histology)
* Diffuse mixed cell
* Immunoblastic
* Relapsed or refractory disease sensitive to initial or subsequent conventional therapy (at least a partial response)
* Eligible for high-dose carmustine, etoposide, cytarabine, and melphalan protocol and autologous bone marrow transplantation or peripheral blood stem cell transplantation
* Evidence of CD20 antigen expression in tumor tissue
* Bidimensionally measurable disease
* Adequate peripheral blood stem cells
* At least 15,000,000 CD34+ cells/kg or
* At least 25,000 granulocyte macrophage colony-forming units/kg
* Age: 19 to 70
* Performance status: Karnofsky 70-100%
* Life expectancy: at least 4 months post-transplantation
* Bilirubin less than 2.0 mg/dL
* Creatinine less than 2.0 mg/dL
* Cardiac ejection fraction at least 40% for any of the following criteria:
* Age 60 and over
* Significant cardiac history (myocardial infarction or congestive heart failure)
* Received greater than 350 mg/m\^2 of prior doxorubicin
* DLCO at least 50% of predicted
* HIV negative
* Fertile patients must use effective contraception during and for at least 6 months after study participation
* At least 4 weeks since prior biologic therapy and recovered
* Human antimouse antibody negative
* At least 4 weeks since prior cytotoxic chemotherapy and recovered
* At least 4 weeks since prior radiotherapy and recovered
* At least 4 weeks since prior immunosuppressants and recovered
Exclusion Criteria:
* No progressive disease in a field that has been previously irradiated with more than 3,500 cGy within the past year
* No known brain or leptomeningeal metastases
* No active obstructive hydronephrosis
* No New York Heart Association class III or IV heart disease
* No evidence of severe organ dysfunction
* No other major medical illnesses
* No active infection requiring IV antibiotics
* No other malignancy within the past 5 years except adequately treated skin cancer or carcinoma in situ of the cervix
* Not pregnant/negative pregnancy test
* No prior peripheral blood stem cell transplantation following high-dose chemotherapy or chemoradiotherapy
* No other concurrent biologic therapy for NHL
* No concurrent steroids except maintenance-dose steroids for noncancerous disease
* No concurrent external beam radiotherapy for NHL
* No other concurrent participation on protocol involving non-FDA-approved drugs or biologics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT00006695
Study Brief:
Protocol Section:
NCT00006695