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WT1 Immunity Via DNA Fusion Gene Vaccination in Haematological Malignancies by Intramuscular Injection Followed by Intramuscular Electroporation
Bu çalışma, Kronik Miyeloid Lösemi (CML) veya Akut Miyeloid Lösemi (AML) hastalarında WT1 proteinine karşı bağışıklık oluşturmayı hedefleyen bir DNA aşısını (kas içine enjeksiyon ve elektroporasyon yöntemiyle) inceliyor. Uygun HLA tipine sahip, ilgili lösemisi olan 18 yaş üstü hastalar dahil edilmiştir. Faz 2 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: * CML patients: Philadelphia chromosome positive CML in chronic phase, in complete cytogenetic response (CCyR) but with detectable BCR-ABL transcripts and maintained the CCyR on imatinib monotherapy for a minimum of 24 months AML patients: WT1+ AML in CR or morphologic CR with incomplete blood count recovery (CRi); All patients: * ≥ 18 years of age, written informed consent * Performance status of 0 or 1. * for vaccination groups: HLA-A0201 positive in at least one allele * for control groups: HLA A2 negative in both alleles * renal function and liver function (Creatinine \<1.5 x upper limit of normal, liver function tests \< 1.5 x upper limit of normal); Lymphocyte count \> 1.0 x109/l; normal clotting * HB\>100 g/l * Adequate venous access for repeated blood sampling according to protocol schedule. * If sexually active and possibly fertile, patients must agree to use appropriate contraceptive methods during the trial and for six months afterwards. Exclusion Criteria: * CML patients: * CML in accelerated phase or blast crisis or having achieved CMR at any point during imatinib therapy. * Imatinib dose modification in the previous year, Imatinib interruption for more than 15 days in the previous 6 months to enrolment * Prior interferon-α therapy * hypocellular bone marrow (\<20%) * Complete molecular response (CMR) AML patients: * AML in haematological relapse or eligible for allogeneic SCT. * hypocellular bone marrow (\<20%) * AML patients with the "good-risk" abnormalities comprised by the core binding factor leukaemias (i.e., AML with the translocation (8;21) and inversion of chromosome 16, and acute promyelocytic leukaemia with the translocation (15;17)) All patients: * Systemic steroids or other drugs with a likely effect on immune competence are forbidden during the trial. The predictable need of their use will preclude the patient from trial entry * Major surgery in the preceding three to four weeks from which the patient has not yet recovered. * Patients who are of high medical risk because of non-malignant systemic disease, as well as those with active uncontrolled infection. * Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial, such as concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease * Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study. * Patients who are serologically positive for or are known to suffer from Hepatitis B, C, Syphilis or HIV. Counselling will be offered to all patients prior to testing.