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)
- Conditions
- Higher-Risk Myelodysplastic Syndromes (MDS) (IPSS Risk: High or INT-2)MedDRA version: 14.1Level: LLTClassification code 10002311Term: Anemia refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10028532Term: MyelodysplasiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-005322-22-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method