Prospective Controlled Clinical Study of Allogeneic Stem Cell Transplantation With Reduced Conditioning (RICT) Versus Best Standard of Care in Acute Myeloid Leukemia (AML)in First Complete Remission (CR)
Sponsor study identifier
interventional
340
9 countries
25
Study Start
December 18, 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 5, 2018
Actual (reported)Study Completion
July 20, 2018
Actual (reported)This study compares overall survival between patients with acute myeloid leukemia, who are in complete remission following initial treatment with chemotherapy and whose remission is maintained either with a transplantation of stem cells obtained from a sibling or unrelated donor or with standard treatment, which is additional chemotherapy. The study hypothesis is that the group transplanted with stem cells from a donor will have a superior survival compared with patients treated with standard of care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 20, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2003
Date type not reportedThis date has not been verified as actual or estimated.
June 20, 2006
Actual (reported)June 21, 2006
Actual (reported)July 5, 2018
Actual (reported)July 20, 2018
Actual (reported)Overall survival (OS)
OS is the time from Inclusion to death, lost to follow-up, refusal, or study termination.
From Inclusion until one of the above events (≥2yrs in all surviving pts).
Disease-free survival
From Inclusion to relapse, death or study termination. Follow-up ≥24 mo in all surviving pts.
Quality of Life for pts in the RICT and Control Groups.
All pts were asked to fill out the instrument at 12 and 24 months after inclusion
Non-relapse mortality (NRM). Numbers and causes of death in non-relapsed pts
From Inclusion to relapse or death until study termination.
Acute and Chronic Graft-versus-Host Disease (GvHD)
Acute GvHD: From transplant to 3 months. Chronic From transplantation to relapse, death or study termination
Receiving intervention consisting of Reduced Intensity Conditioning Stem Cell Transplantation
Treatment according to standard of care, i.e. not undergoing RICT
One of the following conditioning regimens: 1. Busulphan (orally or IV), fludarabine 2. Fludarabine, carmustine, melfalan 3. Cyclophosphamide, fludarabine
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Austalasian Leukaemia &Lymphoma Group Limited
East Melbourne, Victoria, 3002, Australia
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
McMaster Site Ward 3Z, Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5, Canada
Hematology, Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Hématologie, Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
Mats Brune, MD, PhD
Göteborg University
340 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2006
First Posted
June 21, 2006
Contact the study team to confirm eligibility.
Hematology, Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Hématologie, Hospital CHA Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
L'Hôtel Dieu de Quebec
Québec, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Tartu University Hospital
Tartu, 51014, Estonia
Turku University Hospital
Turku, 20520, Finland
Dept of Hematology, University Hospital
Freiburg im Breisgau, 79106, Germany
University Hospital of Patras
Pátrai, 26504, Greece
Christchurch Hospital
Christchurch, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Section of Hematology, National Hospital
Oslo, 0027, Norway
Department of Hematology, Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
Sunderby Hospital
Luleå, Sweden
Skåne University Hospital Lund
Lund, Sweden
University Hospital Örebro
Örebro, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
Karolinska University Hospital Solna
Stockholm, Sweden
Uppsala Akademiska Hospital
Uppsala, Sweden
Study Start
December 18, 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 5, 2018
Actual (reported)Study Completion
July 20, 2018
Actual (reported)Last Updated
January 27, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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