Acute Myeloid Leukemia Clinical Trial
Official title:
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)
Verified date | January 2020 |
Source | Vastra Gotaland Region |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 340 |
Est. completion date | July 20, 2018 |
Est. primary completion date | July 5, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 51 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Newly diagnosed patients with de novo or secondary AML - Intermediate or poor risk - In first complete remission - Age 51-70 years - Fit for the procedure - Fit for further consolidation chemotherapy Exclusion Criteria: - Planned for a full-dose allogeneic transplant |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | Austalasian Leukaemia &Lymphoma Group Limited | East Melbourne | Victoria |
Canada | McMaster Site Ward 3Z, Hamilton Health Sciences | Hamilton | Ontario |
Canada | Hématologie, Maisonneuve-Rosemont Hospital | Montreal | Quebec |
Canada | Hematology, Royal Victoria Hospital | Montreal | Quebec |
Canada | Hematology, Ottawa Hospital | Ottawa | Ontario |
Canada | Hématologie, Hospital CHA Enfant-Jésus | Quebec City | Quebec |
Canada | L'Hôtel Dieu de Quebec | Quebec City | Quebec |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Cancer Care Manitoba | Winnipeg | Manitoba |
Estonia | Tartu University Hospital | Tartu | |
Finland | Turku University Hospital | Turku | |
Germany | Dept of Hematology, University Hospital | Freiburg | |
Greece | University Hospital of Patras | Patras | |
New Zealand | Christchurch Hospital | Christchurch | |
New Zealand | Wellington Hospital | Wellington | |
Norway | Section of Hematology, National Hospital | Oslo | |
Sweden | Department of Hematology, Sahlgrenska University Hospital | Goteborg | |
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 |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region | Australasian Leukaemia and Lymphoma Group, The Canadian Blood and Marrow Transplant Group |
Australia, Canada, Estonia, Finland, Germany, Greece, New Zealand, Norway, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | |
Secondary | Disease-free survival | DFS is the time from Inclusion until date of first documented relapse, death from any cause whichever came first, assessed until study termination. | From Inclusion to relapse, death or study termination. Follow-up =24 mo in all surviving pts. | |
Secondary | Quality of Life for pts in the RICT and Control Groups. | European Organization for Research and Treatment of Cancer (EORTC). Quality of Life Questionnaire (QLQ), Cancer C) #30. An instrument commonly used for the evaluation of QoL after under and after cancer treatment | All pts were asked to fill out the instrument at 12 and 24 months after inclusion | |
Secondary | Non-relapse mortality (NRM). Numbers and causes of death in non-relapsed pts | NRM is death without preceding relapse, from Inclusion to study termination. | From Inclusion to relapse or death until study termination. | |
Secondary | Acute and Chronic Graft-versus-Host Disease (GvHD) | In transplanted pts only. Acute GvHD appears from transplant to 100 days. Chronic GvHD occurs later, and often remains for years. Both are clinical diagnoses and cGvHD grading were performed annually until death or study termination. | Acute GvHD: From transplant to 3 months. Chronic From transplantation to relapse, death or study termination |
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