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

Phase 1

• Conditions: patients with haematologic maliignancies prior to allogenic haematopoietic stem cell; MedDRA version: 6.1Level: HLGTClassification code 10024324

• Registration Number: EUCTR2005-005182-11-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-30
• Study Completion: 2012-01-11
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified