Yükleniyor... / Loading...
Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant
Bu çalışma, daha önce sitomegalovirüs (cytomegalovirus, CMV) enfeksiyonu geçirmiş ve donörden hematopoetik hücre nakli (donor hematopoietic cell transplant) yapılan hastalarda CMV kaynaklı komplikasyonları azaltmak için CMV-MVA Triplex aşısını plaseboyla karşılaştırarak değerlendirmektedir. Çalışmaya, lenfoma ve lösemi gibi kan kanserleri nedeniyle nakil planlanan, CMV açısından pozitif hastalar katılabilmektedir. Çalışma Faz 2 aşamasında yürütülmüş; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
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: * All subjects must have the ability to understand and the willingness to sign a written informed consent * Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT * Planned HCT for the treatment of the following hematologic malignancies: * Lymphoma (Hodgkin and Non-Hodgkin) * Myelodysplastic syndrome * Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood; persistent lymphadenopathy on computed tomography \[CT\] or CT/positron emission tomography (PET) scan without progression is allowed) * Acute myeloid leukemia in first or second remission * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase * Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis; patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded * Patients undergoing a second allogeneic (allo) HCT are not eligible (patients who have undergone a previous autologous HCT are eligible) * CMV seropositive (recipient) * Planned related or unrelated HCT, with 8/8 (A,B,C,DRB1) high/intermediate resolution HLA donor allele matching * Planned HCT with minimal to no-T cell depletion of graft * Conditioning and immunosuppressive regimens according to institutional guidelines are permitted * Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration * Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative) within 2 months of registration * Agreement by females of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for up to 90 days post-HCT; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately Exclusion Criteria: * Any prior investigational CMV vaccine * Experimental anti-CMV chemotherapy in the last 6 months * Live attenuated vaccines * Medically indicated subunit (Engerix-B for HBV; Gardasil for human papillomavirus \[HPV\]) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) * Allergy treatment with antigens injections * Alemtuzumab or any equivalent in vivo T-cell depleting agent * Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)/valganciclovir (VAL), foscarnet (FOS), Cidofovir, CMX-001, maribavir; acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) * Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment * Other investigational product - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited * Other medications that might interfere with the evaluation of the investigational product * Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible * Pregnant women and women who are lactating; breastfeeding should be discontinued if the mother is enrolled on this study * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/ psychological issues, etc * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)