Back to results

Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)

Primary Purpose

Acute Myeloid Leukaemia

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Treosulfan

About this trial

This is an interventional supportive care trial for Acute Myeloid Leukaemia focused on measuring Treosulfan, Fludarabine, ATG, AML

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Rostock

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treosulfan

Arm Description

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

Outcomes

Primary Outcome Measures

Efficacy - Evaluation of engraftment. Safety - Evaluation of the incidence of the following CTC grade 3 and 4 adverse events between day -6 and day +28 - hyperbilirubinemia and mucositis / stomatitis - veno-occlusive disease - seizures

Secondary Outcome Measures

Efficacy - Evaluation of disease free survival (DFS) - Evaluation of overall survival (OS) - Evaluation of relapse incidence (RI) - Donor chimerism on day +28, +56 and +100. Safety - Evaluation of NRM on days +28 and +100

Full Information

NCT ID

NCT01063660

First Posted

February 3, 2010

Last Updated

February 4, 2010

Sponsor

medac GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01063660

Brief Title

Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)

Official Title

Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukaemia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

medac GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukaemia

Keywords

Treosulfan, Fludarabine, ATG, AML

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treosulfan

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Treosulfan

Other Intervention Name(s)

Ovastat

Intervention Description

14 g/m²/d day -6 to -4

Primary Outcome Measure Information:

Title

Time Frame

3.5 years

Secondary Outcome Measure Information:

Title

Time Frame

3.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathias Freund, MD

Organizational Affiliation

University of Rostock

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rostock

City

Rostock

ZIP/Postal Code

18057

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

22158386

Citation

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.

Results Reference

derived

Learn more about this trial

Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)

We'll reach out to this number within 24 hrs