Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00342316|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : January 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Procedure: Reduced Intensity Conditioning Stem Cell Transplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Formally, this is not Phase III study, since there are no new drugs or interventions. Rather - a prospective, controlled study where we include pts aimed for alloSCT before any donor search. Both groups of pts (with or without a matched donor) are followed ≥2yrs. The hypothesis is that pts with a donor do better than those without a donor (sib and/or unrelated).|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 18, 2003|
|Actual Primary Completion Date :||July 5, 2018|
|Actual Study Completion Date :||July 20, 2018|
Experimental: Stem cell transplant (RICT)
Receiving intervention consisting of Reduced Intensity Conditioning Stem Cell Transplantation
Procedure: Reduced Intensity Conditioning Stem Cell Transplantation
One of the following conditioning regimens:
No Intervention: Control arm
Treatment according to standard of care, i.e. not undergoing RICT
- 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.
- Disease-free survival [ Time Frame: From Inclusion to relapse, death or study termination. Follow-up ≥24 mo in all surviving pts. ]DFS is the time from Inclusion until date of first documented relapse, death from any cause whichever came first, assessed until study termination.
- Quality of Life for pts in the RICT and Control Groups. [ Time Frame: All pts were asked to fill out the instrument at 12 and 24 months after inclusion ]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
- Non-relapse mortality (NRM). Numbers and causes of death in non-relapsed pts [ Time Frame: From Inclusion to relapse or death until study termination. ]NRM is death without preceding relapse, from Inclusion to study termination.
- Acute and Chronic Graft-versus-Host Disease (GvHD) [ Time Frame: Acute GvHD: From transplant to 3 months. Chronic From transplantation to relapse, death or study termination ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00342316
|Principal Investigator:||Mats Brune, MD, PhD||Göteborg University|