A Phase II Study exploring the feasibility of Azacitidine and Lenalidomide use (combination vs sequential treatment) for Higher-Risk Myelodysplastic Syndromes (MDS) (IPSS Risk: High or INT-2) - RV-MDS-PI-0550-REV/AZA

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2012年5月24日最近更新: 2014年2月24日

适应症

试验速览

暂无简介。

•A. Male and female patients = 18 years B. Signed informed consent C. Confirmed diagnosis of MDS according to WHO 2008 classification D. IPSS risk Int-2 or High proved by bone marrow aspiration, biopsy and cytogenetics E. Karnofsky score > 60% at study entry F. Adequate renal, pulmonary and hepatic function, intended as follows: • Bilirubin = 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction) • AST and ALT = 3.5 times ULN • Creatinine = 2 times ULN G. HIV negativity H. Females of childbearing potential (FCBP) must undergo pregnancy testing based on the frequency outlined in Appendix 1 and pregnancy results must be negative. I. Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods as specified in Appendix 1 J. Males (including those who have had a vasectomy) must use barrier contraception (condoms) when engaging in sexual activity with FCBP as specified in Appendix 1 K. Males must agree not to donate semen or sperm during the duration specified in Appendix 1
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•A. Prior treatment with Azacitidine or Lenalidomide. B. Any prior chemotherapy or radiotherapy for another malignancy within 6 months C. Prior history of malignancies, other than MDS, unless the subject has been free of the disease for = 3 years. However, subjects with the following history/concurrent conditions may enroll at any time: • Basal cell carcinoma of the skin • Carcinoma in situ of the cervix • Incidental histologic finding of prostate cancer (Tumor Node Metastasis (TNM) stage of T1a or T1b) D. Concurrent chemotherapy for another malignancy E. Known Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection. F. Any of the following laboratory abnormalities: • Serum aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.5 x upper limit of normal (ULN) • Serum bilirubin levels > 2.5 x ULN; serum bilirubin levels > 2.5 x ULN are acceptable if these can be attributed to active hemolysis (as indicated by positive direct Coombs’ testing, decreased haptoglobin level, elevated indirect bilirubin and/or lactate dehydrogenase), or ineffective erythropoiesis (as indicated by bone marrow findings) • Creatinine > 2 times ULN G. Uncontrolled hyperthyroidism or hypothyroidism. H. Absence of patient’s written informed consent I. Current uncontrolled severe infections

发起方

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI