EUCTR2014-000363-40-ESActive, not recruitingNot Applicable
A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE
European Society for Blood and Marrow Transplantation0 sites200 target enrollmentStarted: September 7, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Diagnosis of severe or very severe aplastic anemia, defined by
- •?At least two of the following:
- •?Absolute neutrophil counts <0.5 x 10(9)/L (severe) or
- •<0.2 x 10(9)/L (very severe)
- •?Platelet counts <20 x 10(9)/L
- •?Reticulocyte counts <60 x 10(9)/L
- •?Hypocellular bone marrow (<30% cellularity), without evidences of fibrosis or malignant cells
- •2.Age ? 15 years;
- •3.Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
Exclusion Criteria
- •1.Prior immunosuppressive therapy with ATG (horse of rabbit) or any other lymphocyte depleting agent (i.e., alemtuzumab)
- •2.Eligibility to a sibling allogeneic stem cell transplantation
- •3.Evidence of a myelodysplastic syndrome, defined by the presence of myelodysplastic features, excess of blasts or karyotypic abnormalities typical of MDS (according to revised WHO 2008
- •criteria) , as well as other primitive marrow disease. Patients with diagnosis of AA with cytogenetic abnormalities which are recurrent in MDS (according to revised WHO 2008 criteria) should be included in this category, and are not eligible for the study; patients with del(20q), +8 and ?Y are not included in this category, and thus are eligible for this study. The list of karyotypic abnormalities which qualifies for the diagnosis of MDS are listed in Appendix 1 of the protocol
- •4.History or clinical suspect of constitutional aplastic anemia (i.e. Fanconi Anemia with positive DEB/MMC test or Dyskeratosis Congenita)
- •5.History of malignant tumors with active disease within 5 years from enrollment and/or previous chemo-rediotherapy
- •6.Previous history of stem cell transplantation
- •7.Treatment with cyclosporin A <2 weeks before enrollment
- •8.CMV viremia, as defined by positive PCR or pp65 test
- •9.WHO performance status ?3
- •10.Pregnant or breast feeding patients
- •11.Patients with hepatic, renal or cardiac failure, or any other life-
- •threatening concurrent disease
- •12.Patients with HIV infection
- •13.Patients without social health care assistance
- •14.Participation in another clinical trial within 1 month before the start of this trial
- •15.Subjects with known hypersensitivity to any of the component medications
Investigators
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