Clinical phase II trial to evaluate the safety and efficacy of clofarabine and treosulfan conditioning prior to peripheral blood stem cells transplantation in paediatric and adult patients with advanced haematological malignancies - ND

OSPEDALE S. RAFFAELE0 sitesNovember 12, 2008

Overview

No summary available.

Registry

who.int

Start Date

November 12, 2008

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

OSPEDALE S. RAFFAELE

•Patients with haematological malignancies such as
•\- acute myeloid leukaemia \-AML\- beyond CR1
•\- acute lymphoblast leukaemia \-ALL\- beyond CR1
•\- chronic myeloid leukaemia \-CML\- beyond chronic phase (CP1\)
•\- myelodysplastic syndrome \-MDS\- such as RCMD, RAEB1 and RAEB2
•Availability of a
•\-HLA\-identical sibling donor (MRD) or
•\-HLA\-identical unrelated donor (MUD) with HLA\-identity defined by the following markers: A and B at antigenic level; DRB1 at allelic level. However every patient and donor will be typed at allelic level at HLA\-A, B, C, DRB1, DQB1\. If no class I and class II completely identical donor (i.e. 10 out of 10\) can be identified, no more than two allele disparity between patient and donor is acceptable. The target graft size (unmanipulated) will be: 4 \- 10 x 106 CD34\+ cells/kg BW recipient
•Have adequate renal and hepatic functions as indicated by the following laboratory values:
•Pediatric Population: Calculated creatinine clearance \&\#8805; 90 ml/min/1\.73m2 as calculated by the Schwartz formula for estimated glomerular filtration rate (GFR) where GFR (ml/min/1\.73 m2\) \= k\*Height (cm)/serum creatinine (mg/dl). k is a proportionality constant which varies with age and is a function of urinary creatinine excretion per unit of body size; 0\.45 up to 12 months of age; 0\.55 children and adolescent girls; and 0\.70 adolescent boys.

•1\.Secondary malignancies
•2\.Previous allogeneic transplantation
•3\.Hematopoietic cell transplantation\-specific comorbidity index (HCT\-CI \> 4 (Sorror et al Appendix M)
•1\.Secondary malignancies
•2\.Previous allogeneic transplantation
•3\.Hematopoietic cell transplantation\-specific comorbidity index (HCT\-CI \> 4 (Sorror et al Appendix M)
•4\.HIV\- positivity or active hepatitis infection
•5\.Pleural effusion or ascites \> 1\.0 L
•6\.Pregnancy or lactation
•7\.Known hypersensitivity to treosulfan and/or clofarabine