ALEMTUZUMAB AND LOW-DOSE CYCLOSPORINE-A AS ALTERNATIVE IMMUNOSUPPRESSIVE TREATMENT FOR SEVERE APLASTIC ANEMIA (SAA) AND SINGLE-LINEAGE APLASTIC PATIENTS. - Alesaa

IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II0 个研究点目标入组 50 人开始时间: 2011年6月14日最近更新: 2012年4月3日

试验速览

暂无简介。

•a.Diagnosis of severe or very severe aplastic anemia,22 defined by:
•At least two of the following:
•Absolute neutrophil counts <0.5 x 109/L (severe) or <0.2 x 109/L (very severe)
•Platelet counts <20 x 109/L
•Reticulocyte counts <20 x 109/L
•Hypocellular bone marrow (<30% cellularity), without evidences of fibrosis or malignant cells
•Diagnosis of single lineage acquired marrow failure, such as:
•Pure Red Cell Aplasia (PRCA
•Agranucytosis
•Amegakaryocytic thrombocytopenia
•b.Failure of first line therapy with ATG+CsA, or lack of eligibily for ATG-based studies. Failure is defined as follows:
•-lack of hematological response
•-need of chronic IS treatment to sustain response
•c.Age ≥18 years
•d.Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•a.Eligibility for a low-risk SCT procedure
•b.Evidence of a risky myelodysplastic syndrome (IPSS 3-4), defined by the presence of marrow blast excess or karyotypic abnormalities, or other primitive marrow disease
•c.History of constitutional aplastic anemia (i.e. Fanconi Anemia or Dyskeratosis Congenita)
•d.History of malignant tumors with active disease within 5 years from enrollment
•e.Previous history of allogeneic stem cell transplantation
•f.Treatment with cyclosporin A <2 weeks before enrollment
•g.Treatment with G-CSF <2 weeks before enrollment
•h.CMV viremia, as defined by positive PCR or pp65 test
•i.WHO performance status ≥3
•j.Pregnant or breast feeding patients
•k.Patients with hepatic (transaminases >UNLx3 or albumin <1,5 g/L), renal (creatinine >UNLx3) or cardiac failure (ejection fraction <35%), or any other life-threatening concurrent disease (including HIV infection).

发起方

IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II