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Treatment of Chronic Lymphocytic B-Leukemia With IL-2 and CD-40 Autologous Tumor Cells
Bu çalışma, kronik lenfositik lösemi (chronic lymphocytic leukemia) olan hastalarda, IL-2 salgılayan ve CD40L taşıyan, hastanın kendi tümör hücrelerinden hazırlanan bir aşı tedavisini incelemiştir. Çalışmaya, B hücreli kronik lenfositik lösemisi olan ve belirli ölçütleri karşılayan hastalar katılabilmiştir. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Patients are eligible for administration of their vaccine if they present with B-CLL (not in Richter's transformation) with (group A) or without (group B) measurable disease. Untreated or complete remission patients will be enrolled for vaccine administration in a therapeutic (i.e. no chemotherapy) window of three months. If during these three months (necessary to complete the vaccine study) the patient presents with rapid clinical progression, he or she will be excluded from our current study and will receive treatment according to the standard institutional guidelines. IMPORTANT NOTE: Vaccine production for complete remission patients can only be achieved if tumor cells have been collected BEFORE entering complete remission. * Patients must have a life expectancy of at least 10 weeks. * Patients must have ECOG performance status of 0-2. * Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and must have an absolute neutrophil count of \>/= 500/uL, absolute lymphocyte count \>/= 200/uL, hemoglobin \>/= 8g/dL and platelet count \>/= 50,000/uL. * Patients must not be infected at time of protocol entry, and should not be receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole). * Patients must be HIV-negative. * Patients must be willing to practice appropriate birth control methods during the study and for 3 months after the study is concluded. * Patients must not be suffering from an autoimmune disease (including active graft-versus-host disease-GvHD, refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA) and should not be receiving immunosuppressive drugs. * Patients must have adequate liver function (total bilirubin \</= 1.5mg/dl, SGOT \</= 2 times normal, normal prothrombin time). * Patients must have adequate renal function (creatinine \< 3 times normal for age or creatinine clearance \> 80mg/min/1.73m2). * Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side-effects. Patients will be given a copy of the consent form. * Patient must not have received treatment with other investigational agents within the last 4 weeks. Exclusion Criteria: * Richter's transformation (aggressive non-Hodgkin's lymphoma) * active infection * significant autoimmune disease (including active GvHD, ITP and AIHA) * requirement for immunosuppressive drugs * inadequate liver and/or renal function * pregnancy or lactation * refusal to practice birth control methods * seropositive for HIV * life expectancy less than 10 weeks