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High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma
Bu Faz 1 (Phase 1) çalışma, yüksek doz kemoterapi (high-dose chemotherapy, HDT) ve otolog kök hücre nakli (autologous stem cell transplantation, ASCT) sonrasında hastanın kendi bağışıklık hücrelerinin (19-28z CAR T hücreleri) verilmesinin güvenliğini test etmektedir. Kemoterapi rejiminde karmustin, etoposid, sitarabin ve melfalan ile pegfilgrastim kullanılmaktadır. Çalışmaya, nüks etmiş ya da dirençli diffüz büyük B hücreli lenfoma (diffuse large B-cell lymphoma, DLBCL) ve transforme foliküler lenfoma gibi agresif B hücreli Hodgkin dışı lenfoma (non-Hodgkin lymphoma) alt tipleri olan, 18 yaş ve üzeri nakle uygun hastalar alınmaktadır.
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.
Transplant eligible patients will be eligible if criteria met per below. Inclusion Criteria: * Patients ≥ 18 years of age with aggressive B-cell non-Hodgkin lymphoma subtypes including, relapsed or refractory diffused large B-cell lymphoma (DLBCL), and transformed follicular lymphoma meeting at least one of the following criteria: * Bone marrow involvement at the time of relapse or refractory disease and not appropriate for allogeneic transplantation. * PET positive disease outside of one radiation port unless single-port disease treated with prior radiotherapy within the port, following \> or = to 2 cycles of salvage chemotherapy, still achieving chemosensitive status 1999 IWG criteria (section 12.2 and 12.383). * Creatinine ≤ 1.5 mg/100 ml (or measured 24 hour creatinine clearance of ≥ 50 cc/min) * Bilirubin \<2.0 mg/100 ml, AST and ALT \<3x the upper-limit of normal, PT and PTT \< 2x normal outside the setting of stable chronic anticoagulation therapy, * Adequate cardiac function (LVEF\>40%) as assessed by ECHO or MUGA scan performed within 1 month of treatment. * Adequate pulmonary function as assessed by DLCO of \> or = to 45% adjusted for hemoglobin. * Life expectancy of \> 3 months. Exclusion Criteria: * Karnofsky performance status ≤ 70 (see appendix VI). * Patients with other aggressive B-cell malignancies including, but not limited to: Burkitt lymphoma, transformed CLL/SLL and transformed marginal zone lymphoma that are not included in 6.1 inclusion criteria. * Patients previously treated with autologous or allogeneic bone marrow or stem cell transplantation are ineligible. * Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study. * Uncontrolled bacterial, viral or fungal infection. * Patients with HIV, active hepatitis B or hepatitis C infection.