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Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00342316
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
The Canadian Blood and Marrow Transplant Group
Australasian Leukaemia and Lymphoma Group
Information provided by (Responsible Party):
Vastra Gotaland Region

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.


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Procedure: Reduced Intensity Conditioning Stem Cell Transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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:

  1. Busulphan (orally or IV), fludarabine
  2. Fludarabine, carmustine, melfalan
  3. Cyclophosphamide, fludarabine

No Intervention: Control arm
Treatment according to standard of care, i.e. not undergoing RICT



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Vastra Gotaland Region
The Canadian Blood and Marrow Transplant Group
Australasian Leukaemia and Lymphoma Group
Investigators
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Principal Investigator: Mats Brune, MD, PhD Göteborg University
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT00342316    
Other Study ID Numbers: TRALG1/02
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vastra Gotaland Region:
Acute Myeloid Leukemia
Stem Cell Transplantation
Reduced Intensity Conditioning
Survival
Relapse
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms