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This study examines a vaccine therapy prepared from the patient's own tumor cells and containing GM-CSF and GM.CD40L, given together with chemotherapy, in patients with mantle cell lymphoma. It enrolled patients aged 18 and older with stage II, III, or IV disease, whether newly diagnosed or relapsed. The research was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS: * Histologically confirmed mantle cell lymphoma * Stage II, III, or IV disease * Relapsed or de novo disease * No symptomatic brain metastasis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * Not specified Hematopoietic * White blood count (WBC) \> 3,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hematocrit \> 25% * Hemoglobin \> 8 g/dL Hepatic * Bilirubin \< 2.0 mg/dL Renal * Creatinine \< 2.0 mg/dL OR * Creatinine clearance \> 60 mL/min Immunologic * No serious ongoing infection * No known HIV infection * No other pre-existing immunodeficiency condition Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * No other concurrent immunotherapy Chemotherapy * More than 4 weeks since prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * More than 4 weeks since prior steroids * No concurrent corticosteroids except as replacement doses in patients who are hypoadrenal Radiotherapy * More than 2 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * No other concurrent immunosuppressive therapy