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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


Phase 2
18 Years
60 Years
Not Enrolling
Both
Acute Myeloid Leukaemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

3.5 years

Safety Issue:

Yes

Principal Investigator

Mathias Freund, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rostock

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

MC-FludT.7/AML

NCT ID:

NCT01063660

Start Date:

March 2004

Completion Date:

July 2007

Related Keywords:

  • Acute Myeloid Leukaemia
  • Treosulfan
  • Fludarabine
  • ATG
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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