Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)

NCT ID: NCT01063660

Last Updated: 2010-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2007-07-31

Brief 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.

Conditions

Acute Myeloid Leukaemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treosulfan

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

Group Type: EXPERIMENTAL

Treosulfan

Intervention Type: DRUG

14 g/m²/d day -6 to -4

Interventions

Treosulfan

14 g/m²/d day -6 to -4

Intervention Type: DRUG

Other Intervention Names

Ovastat

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

medac GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

University of Rostock

Principal Investigators

Mathias Freund, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rostock

Locations

University of Rostock

Rostock, , Germany

Countries

Germany

References

Casper J, Holowiecki J, Trenschel R, Wandt H, Schaefer-Eckart K, Ruutu T, Volin L, Einsele H, Stuhler G, Uharek L, Blau I, Bornhaeuser M, Zander AR, Larsson K, Markiewicz M, Giebel S, Kruzel T, Mylius HA, Baumgart J, Pichlmeier U, Freund M, Beelen DW. Allogeneic hematopoietic SCT in patients with AML following treosulfan/fludarabine conditioning. Bone Marrow Transplant. 2012 Sep;47(9):1171-7. doi: 10.1038/bmt.2011.242. Epub 2011 Dec 12.

Reference Type: DERIVED

PMID: 22158386 (View on PubMed)

Other Identifiers

MC-FludT.7/AML

Identifier Type: -

Identifier Source: org_study_id