Clinical phase II trial to evaluate the safety and efficacy of treosulfan based conditioning prior to allogenic haematopoietic stem cell transplantation in patients with haematological malignancies. - ND

OSPEDALE S. RAFFAELE0 sites0 target enrollmentMarch 30, 2006

Overview

No summary available.

Registry

who.int

Start Date

March 30, 2006

End Date

January 11, 2012

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

OSPEDALE S. RAFFAELE

•1\.Patients with haematological malignancies acute myeloid leukaemia\-AML, acute lymphoblast leukemia\-ALL, chronic myeloid leukemia\-CML, myelodysplastic syndrome\-MDS, diffuse large cell lymphoma\-DLCL, Hodgkin lymphoma, chronic lymphocytic leukemia\-CLL, multiple myeloma\-MM or other heamatological malignancies indicated for allogeneic transplantation .2\.Availability of an HLA\-identical sibling donor MRD or HLA\-identical unrelated donor MUD HLA\-identity defined by the following markers A, B, DRB1, DQB1\. 3\. Target graft size unmanipulated \- bone marrow 2 \- 10 x 106 CD34 cells/kg BW recipient or 2 x 108 nucleated cells/kg BW recipient or \- peripheral blood 4 \- 10 x 106 CD34 cells/kg BW recipient4\. Age 18 and 70 years 65 for MUD only 5\. Karnofsky Index 80 6\. Adequate contraception in female patients of child\-bearing potential 7\. 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) no
•F.1\.3\.1 Number of subjects for this age range

•1\. Secondary malignancies2\. Previous allogeneic transplantation3\. Severe concomitant illnesses / medical conditions e.g. impaired respiratory and/or cardiac function 4\. Known and manifested malignant involvement of the CNS 5\. Active infectious disease 6\. HIV\- positivity or active hepatitis infection7\. Impaired liver function Bilirubin upper normal limit; Transaminases 3\.0 x upper normal limit 8\. Impaired renal function Creatinine\-clearance 60 ml/min; Serum Creatinine 1\.5 x upper normal limit .9\. Pleural effusion or ascites 1\.0 L 10\. Pregnancy or lactation11\. Known hypersensitivity to treosulfan and/or fludarabine12\. Participation in another experimental drug trial within 4 weeks before day \-613\. Non\-co\-operative behaviour or non\-compliance 14\. Psychiatric diseases or conditions that might impair the ability to give informed consent