Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, multinational, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with AML.

The aim is to demonstrate a clinical benefit compared with historical data on intravenous busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication conditioning before allogeneic stem cell transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: medac GmbH
• Treatments: Busulfan; Treosulfan

Criteria

Inclusion Criteria:

• Patients with acute myeloid leukaemia (AML) according to WHO classification (> 20% myeloblasts in peripheral blood or bone marrow at initial diagnosis) with < 5% myeloblast in the bone marrow, indicated for allogeneic transplantation

• 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.

• 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 recipient

• Age > 18 and < 60 years

• Karnofsky Index > 80 %

• Adequate contraception in female patients of child-bearing potential

• Written informed consent

Exclusion Criteria:

• Therapy related secondary AML

• AML with t(8;21)(q22;q22) in CR1

• Acute promyelocytic leukaemia with t(15;17)(q22;q12) in CR1

• Secondary malignancies

• Previous allogeneic transplantation

• Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function)

• Known and manifested malignant involvement of the CNS

• Active infectious disease

• HIV- positivity or active hepatitis infection

• Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit)

• Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit).

• Pleural effusion or ascites > 1.0 L

• Pregnancy or lactation

• Known hypersensitivity to treosulfan and/or fludarabine

• Participation in another experimental drug trial within 4 weeks before day -6

• Non-co-operative behaviour or non-compliance

• Psychiatric diseases or conditions that might impair the ability to give informed consent