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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 340
- Locations
- 42
- Primary Endpoint
- Overall survival (OS)
Study Overview
Brief Summary
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.
Detailed Description
Objectives:
The primary objective of this study is to determine whether RICT leads to an improved overall survival compared to conventional treatment for AML.
The secondary objectives of this study are to determine if:
-
RICT leads to a superior long-term overall survival compared to conventional therapy.
-
RICT leads to a superior disease-free survival compared to conventional therapy.
-
Time to relapse is different between RICT and control groups.
-
Quality of life is different between the two treatment groups.
-
in RICT patients only:
-
Safety and feasibility of the procedure
-
Incidence and severity of acute and chronic Graft versus Host Disease (GvHD)
-
Rate of complete and partial chimerism
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 51 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: From Inclusion until one of the above events (≥2yrs in all surviving pts).
OS is the time from Inclusion to death, lost to follow-up, refusal, or study termination.
Secondary Outcomes
- Non-relapse mortality (NRM). Numbers and causes of death in non-relapsed pts(From Inclusion to relapse or death until study termination.)
- 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)
- Acute and Chronic Graft-versus-Host Disease (GvHD)(Acute GvHD: From transplant to 3 months. Chronic From transplantation to relapse, death or study termination)