Dose-reduced Versus Standard Conditioning in MDS/sAML

Summary

In this trial dose reduced conditioning is compared to standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML.

Conditioning is the very high dose chemotherapy treatment that is given in the days before the stem cell transplant.

The hypothesis is that a dose reduced conditioning will reduce the non-relapse mortality from 40% to 20% at one year after allogeneic stem cell transplantation.

Conditions

• Myelodysplastic Syndromes
• Secondary Acute Myeloid Leukemia

Interventions

OTHER

Reduced Intensity Conditioning

Busilvex®: 6.4 mg/kg IBW i. v. day -7: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -6: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) or (if i.v.-application is not available) Busulfan: 8.0 mg/kg BW p. o.: day -7: 4.0 mg/kg BW day -6: 4.0 mg/kg BW plus: Fludarabine: 5 x 30 mg/m² BS i. v.: day -7: 30 mg/m² BS day -6: 30 mg/m² BS day -5: 30 mg/m² BS day -4: 30 mg/m² BS day -3: 30 mg/m² BS

OTHER

Myeloablative conditioning

Busilvex®: 12.8 mg/kg IBW i. v.; day -9: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -8: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -7: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -6: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) or (if i.v.-application is not available): Busulfan: 16.0 mg/kg BW p. o.; day -9: 4.0 mg/kg BW day -8: 4.0 mg/kg BW day -7: 4.0 mg/kg BW day -6: 4.0 mg/kg BW plus: Cyclophosphamide: 120 mg/kg BW i. v.; day -4: 60 mg/kg BW day -3: 60 mg/kg BW

Sponsors & Collaborators

• Pierre Fabre Medicament

  collaborator INDUSTRY

• European Society for Blood and Marrow Transplantation

  lead NETWORK

Principal Investigators

• Nicolaus Kröger, MD · Universitätsklinikum Hamburg-Eppendorf

• Axel R Zander, MD · University Hospital Hamburg-Eppendorf, Germany

• Ghulam J Mufti, MD · King's College Hospital London, United Kingdom

• Marie Robin, MD · Hopital Saint-Louis Paris, France

• Kathrin Haifa Al-Ali, MD · University Hospital Leipzig, Germany

• Dietger Niederwieser, MD · University Hospital Leipzig, Germany

• Giorgio Lambertenghi Deliliers · IRCCS Ospedale Maggiore of Milan, Italy

• Domink Heim, Prof. · University Hospital, Basel, Switzerland

• Liisa Volin, MD · Helsinki University Central Hospital, Finland

• Stefano Guidi, MD · Careggi Hospital - Florence, Italy

• Augustin Ferrant, MD · Cliniques Universitaires St. Luc Bruxelles, Belgium

• Afanasyer Boris · SPB Pavlov Medical Univ, St. Petersburg, Russia

• Kai Hubel · University of Cologne

• Peter Dreger · Univ Hospital Heidelberg - Germany

• Martin Gramatzlle · University Hospital Münster - Germany

• Gerhard Behre · Martin-Luther-Universitaet Halle-Wittenberg - Germany

• Martin Gramatzlle · Univ Hospital Kiel - Germany

• Allione Bernardino · Santi Antonio E Biagio

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-05-31

Primary Completion

2015-01-31

Completion

2015-02-28

Countries

• Germany
• Italy
• Netherlands
• Russia

Study Locations