Dose-Reduced Versus Standard Conditioning Prior Allo SCT for MDS/sAML Patients
Tracking InformationStart Date ICMJE | May 2004 |
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Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: September 17, 2008) | non relapse mortality [ Time Frame: every 6 months for safety and in the final analysis at one year after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ] |
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Original Primary Outcome Measures ICMJE (submitted: May 16, 2008) | 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. [ Time Frame: 1 year after SCT ] [ Designated as safety issue: No ] |
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Change History | Complete list of historical versions of study NCT00682396 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: September 17, 2008) | - 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 ] [ Designated as safety issue: Yes ]
- Incidence of aGvHD [ Time Frame: every 6 months for safety and in the final at day +100 after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
- Incidence of cGvHD [ Time Frame: every 6 months for safety and in the final analysis at one year after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
- event-free survival [ Time Frame: every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
- cumulative incidence of relapse [ Time Frame: every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
- VOD [ Time Frame: every 6 months for safety and in the final analysis at day +100 after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Haematopoietic recovery [ Time Frame: every 6 months for safety and in the final analysis at day +30 after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
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Original Secondary Outcome Measures ICMJE (submitted: May 16, 2008) | Comparison of: hematopoeitic recovery by day +30/ toxicity/ overall survival 2yrs post-transplant/ event-free survival 2yrs post-transplant/ VOD/ incidence of infection. Incidence of: aGvHD by day +100/ cGvHD by day +365/ relapse 2yrs post-transplant [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: No ] |
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Descriptive InformationBrief Title ICMJE | Dose-Reduced Versus Standard Conditioning Prior Allo SCT for MDS/sAML Patients |
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Official Title ICMJE | Dose-Reduced Versus Standard Conditioning Followed by Allogeneic Stem Cell Transplantation in Patients With MDS or sAML: A Randomised Phase III Study |
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Brief Summary | The present study is a multicenter, prospective phase III-study comparing dose-reduced versus standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML. The hypothesis is that dose-reduced conditioning will reduce the non-relapse mortality from 40% to 20% at one year after allogeneic stem cell transplantation. |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | - Myelodysplastic Syndrome
- Secondary Acute Myeloid Leukemia
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Intervention ICMJE | - Procedure: Standard conditioning prior allo SCT
Busilvex 12.8 mg/kg IBW i.v. - day -9: 0.8 mg/kg IBW x 4 (every 6 hours)
- day -8: 0.8 mg/kg IBW x 4 (every 6 hours)
- day -7: 0.8 mg/kg IBW x 4 (every 6 hours)
- day -6: 0.8 mg/kg IBW x 4 (every 6 hours)
OR 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
- Procedure: Dose-reduced conditioning prior allo SCT
Busilvex 6.4 mg/kg IBW i.v. - day -7: 0.8 mg/kg IBW x 4 (every 6 hours)
- day -6: 0.8 mg/kg IBW x 4 (every 6 hours)
OR 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/m^2 BS i.v.: - day -7: 30 mg/m^2 BS
- day -6: 30 mg/m^2 BS
- day -5: 30 mg/m^2 BS
- day -4: 30 mg/m^2 BS
- day -3: 30 mg/m^2 BS
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Study Arms / Comparison Groups | - A: Active Comparator
Standard conditioning Intervention: Procedure: Standard conditioning prior allo SCT - B: Experimental
Dose-reduced conditioning Intervention: Procedure: Dose-reduced conditioning prior allo SCT
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Recruitment InformationEstimated Enrollment ICMJE | 160 |
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Estimated Completion Date | May 2013 |
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Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: Exclusion Criteria: |
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Gender | Both |
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Ages | 18 Years to 65 Years |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | |
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Location Countries ICMJE | Germany, Italy, Netherlands, Russian Federation |
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Administrative InformationNCT ID ICMJE | NCT00682396 |
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Responsible Party | Prof. N. Kroeger, European Group for Blood and Marrow Transplantation |
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Study ID Numbers ICMJE | RICMAC, EBMT 42205525 |
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Study Sponsor ICMJE | Universitätsklinikum Hamburg-Eppendorf |
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Collaborators ICMJE | Pierre Fabre Medicament |
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Investigators ICMJE | Study Chair: | Nicolaus Kröger, MD | University Medical Center Hamburg-Eppendorf, Germany | | Study Chair: | Theo de Witte, MD | University Hospital Nijmegen, The Netherlands | | Principal Investigator: | Axel R. Zander, MD | University Medical Center 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: | Hartmut Biersack, MD | University Hospital, Essen | | Principal Investigator: | Christoph Schmid, MD | Klinikum Augsburg, Germany | | Principal Investigator: | Kathrin Haifa Al-Ali, MD | University Hospital Leipzig, Germany | | Principal Investigator: | Dietger Niederwieser, MD | University Hospital Leipzig, Germany | | Principal Investigator: | Francesco Onida, MD | IRCCS Ospedale Maggiore di Milano, Italy | | Principal Investigator: | Alois Gratwohl, MD | University Horpital Basel, Switzerland | | Principal Investigator: | Tapani Ruutu, MD | Helsinki University Central Hospital, Finland | | Principal Investigator: | Giorgio Lambertenghi Deliliers, MD | IRCCS Ospedal Maggiore di Milano, Italy | | Principal Investigator: | Augustin Ferrant, MD | Cliniques Universitaires St. Luc Bruxelles, Belgium | |
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Information Provided By | Universitätsklinikum Hamburg-Eppendorf |
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