Phase III 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 - RICTin AM

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 300

Inclusion Criteria

AML of intermediate or poor prognosis, in first complete remission following one or more courses of induction therapy - Age 50-70 years - Judged to be able to tolerate a RICT if a suitable donor is found -Judged to be able to tolerate conventional chemotherapy - Willing to undergo a RICT if a suitable donor is found - Signed informed consent prior to inclusion - Willing and able to comply with protocol requirements - At least one sibling without evident contraindications to the donation procedures and who is willing to have a blood sample drawn for HLA-typing.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

AML with good risk features - Additional malignancy which might interfere with the primary endpoint of the study - serum creatinine >2 x the ULN - Abnormal liver function: ALT or AST > 3 x ULN - Planned to receive a full-dose conditioning or an URD transplant - Severe concurrent illness, such as congestive heart failure, severe arrhythmias, uncontrolled hypertension, diabetes, severe neurologic or psychiatric disorder, known HIV-positivity - Ongoing or suspected significant infection - Results of sibling's HLA-typing available

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if reduced intensity conditioning transplantation (RICT) leads to an improved overall survival at three years compared to conventional treatment for acute myeloid leukemia.;Secondary Objective: To determine if:<br>- RICT leads to a superior long-term overall survival compared to conventional therapy<br>- RICT leads to a superior disease-free survival compared to conventional therapy<br>- Time to relapse is different between RICT and control groups<br>- Quality of Life is different between RICT and control groups<br>- In RICT patients only: Safety and feasibility of the procedure, incidence and severity of acute and chronic GvHD, rate of complete and partial chimerism, safety and efficacy of donor lymphocyte infusions for relapse or minimal residual disease;Primary end point(s): Overall survival at three years. Overall survival is defined as the time from inclusion until the date of the latest follow-up or death by any cause

Secondary Outcome Measures

Name	Time	Method

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