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Dose-reduced Versus Standard Conditioning in MDS/sAML (RICMAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01203228
Recruitment Status : Terminated
First Posted : September 16, 2010
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Pierre Fabre Medicament
Information provided by (Responsible Party):
European Society for Blood and Marrow Transplantation

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Secondary Acute Myeloid Leukemia Other: Reduced Intensity Conditioning Other: Myeloablative conditioning Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose-reduced Versus Standard Conditioning Followed by Allogeneic Stem Cell Transplantation in Patients With MDS or sAML: A Randomised Phase III Study (RICMAC)
Study Start Date : May 2004
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
Myeloablative conditioning
 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

Other Names:
  • Myleran
  • Sulphabutin
  • Busulphan
  • Leucosulfan
  • Myeloleukon
  • Citosulfan
  • Mielevcin
  • Milecitan
  • cyclophosphamide
  • Procytox
  • Cytoxan
  • Cyclophosphan
  • Cytophosphan
  • Claphene
  • Cyclostin
  • Endoxan
Experimental: B
Reduced Intensity Conditioning
 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 Names:
  • Myleran
  • Sulphabutin
  • Busulphan
  • Leucosulfan
  • Myeloleukon
  • Citosulfan
  • Mielevcin
  • Milecitan
  • Fludara
  • Beneflur
  • Fludura
  • FAMP
  • 2-Fluoro-ara-AMP


Outcome Measures
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Primary Outcome Measures :
  1. non-relapse mortality [ Time Frame: every 6 months for safety and in the final analysis at one year after allogeneic stem cell transplantation ]

Secondary Outcome Measures :
  1. organ related toxicity of conditioning [ Time Frame: every 6 months for safety and in the final analysis at day +30 after allogeneic stem cell transplantation ]
  2. Incidence of aGVHD [ Time Frame: every 6 months for safety and in the final analysis at day +100 after allogeneic stem cell transplantation ]
  3. incidence of cGVHD [ Time Frame: every 6 months for safety and in the final analysis at one year after allogeneic stem cell transplantation ]
  4. overall survival [ Time Frame: every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation ]
  5. event-free survival [ Time Frame: every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation ]
  6. cumulative incidence of relapse [ Time Frame: every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation ]
  7. VOD [ Time Frame: every 6 months for safety and in the final analysis at day +100 after allogeneic stem cell transplantation ]
  8. infection incidence [ Time Frame: every 6 months for safety and in the final analysis at day +100, 1 year and 2 years after allogeneic stem cell transplantation ]
  9. Haematopoeitic recovery [ Time Frame: every 6 months for safety and in the final analysis at day +30 after allogeneic stem cell transplantation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Disease: Cytologically proven primary or therapy-related myelodysplastic syndrome (MDS), either as

    • refractory anaemia (RA) according FAB or RA with or without dysplasia according WHO,
    • refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with or without dysplasia according WHO,
    • refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or RAEB II according WHO,
    • refractory anaemia with excess of blast in transformation (RAEB T) according FAB,
    • CMML (dysplastic type) according WHO,
  • or secondary acute myeloid leukaemia (sAML).
  • Blast count < 20 percent in bone marrow with or without chemotherapy at time of transplantation.
  • Patient eligible for standard and dose-reduced conditioning as per local guideline.
  • Patient age 18 - 60 years if donor is a HLA-matched unrelated donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one mismatch allowed):
  • Patient age 18 - 65 years if donor is a HLA-matched related donor ((HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one anti¬gen-mismatch allowed):
  • No major organ dysfunction.
  • Written informed consent of the patient.

Exclusion Criteria:

  • Blasts > 20 % in bone marrow at time of transplantation
  • No written informed consent.
  • Central nervous involvement.
  • Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
  • Total bilirubin, SGPT or SGOT > 2 times upper the normal level.
  • Left ventricular ejection fraction < 30 %.
  • Creatinine clearance < 30 ml/min.
  • DLCO < 35 % and/or receiving supplementary continuous oxygen.
  • Positive serology for HIV.
  • Pregnant or lactating women.
  • Patients with a life-expectancy of less than six months because of another debilitating disease.
  • Serious psychiatric or psychological disorders.
  • Invasive fungal infection at time of registration.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203228


Locations
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Germany
University Hospital
Düsseldorf, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany
University Hospital Eppendorf
Hamburg, Germany
University Hospital
Heidelberg, Germany
UKSH Campus Kiel
Kiel, Germany
University Hospital
Köln, Germany
University Hospital
Leipzig, Germany
Universitätsklinikum Munster
Munster, Germany
University Hospital
Tübingen, Germany
Italy
Santi Antonio e Biagio
Alessandria, Italy
Ospedale di Careggi
Firenze, Italy
Ospedale Maggiore di Milano
Milano, Italy
Netherlands
Radboud University MC
Nijmegen, Netherlands
Russian Federation
SPb State I. Pavlov Medical University
St. Petersburg, Russian Federation
Sponsors and Collaborators
European Society for Blood and Marrow Transplantation
Pierre Fabre Medicament
Investigators
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Study Chair: Nicolaus Kröger, MD Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Axel R Zander, MD University Hospital Hamburg-Eppendorf, Germany
Principal Investigator: Ghulam J Mufti, MD King's College Hospital London, United Kingdom
Principal Investigator: Marie Robin, MD Hopital Saint-Louis Paris, France
Principal Investigator: Kathrin Haifa Al-Ali, MD University Hospital Leipzig, Germany
Principal Investigator: Dietger Niederwieser, MD University Hospital Leipzig, Germany
Principal Investigator: Giorgio Lambertenghi Deliliers IRCCS Ospedale Maggiore of Milan, Italy
Principal Investigator: Domink Heim, Prof. University Hospital, Basel, Switzerland
Principal Investigator: Liisa Volin, MD Helsinki University Central Hospital, Finland
Principal Investigator: Stefano Guidi, MD Careggi Hospital - Florence, Italy
Principal Investigator: Augustin Ferrant, MD Cliniques Universitaires St. Luc Bruxelles, Belgium
Principal Investigator: Afanasyer Boris SPB Pavlov Medical Univ, St. Petersburg, Russia
Principal Investigator: Kai Hubel University of Cologne
Principal Investigator: Peter Dreger Univ Hospital Heidelberg - Germany
Principal Investigator: Martin Gramatzlle University Hospital Münster - Germany
Principal Investigator: Gerhard Behre Martin-Luther-Universitaet Halle-Wittenberg - Germany
Principal Investigator: Martin Gramatzlle Univ Hospital Kiel - Germany
Principal Investigator: Allione Bernardino Santi Antonio E Biagio
More Information
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Additional Information:

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Responsible Party: European Society for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier: NCT01203228    
Obsolete Identifiers: NCT00682396
Other Study ID Numbers: 2005-002011-24
EBMT 42205525
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015
Keywords provided by European Society for Blood and Marrow Transplantation:
Reduced Intensity conditioning
Myeloablative conditionig
Allogeneic stem cell transplantation
MUD
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Cyclophosphamide
Busulfan
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites