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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Vastra Gotaland Region
Sponsor:
Collaborators:
The Canadian Blood and Marrow Transplant Group
Australasian Leukaemia and Lymphoma Group
Information provided by (Responsible Party):
Vastra Gotaland Region
ClinicalTrials.gov Identifier:
NCT00342316
First received: June 20, 2006
Last updated: January 14, 2016
Last verified: November 2015
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Procedure: Reduced Intensity Conditioning Stem Cell Transplantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Vastra Gotaland Region:

Primary Outcome Measures:
  • Overall survival at 3 years after inclusion [ Time Frame: From inclusion until death from any cause or after 36 months, whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to relapse from inclusion up to 3 years [ Time Frame: Time between inclusion and date of relapse or after 36 months, whichever comes first. ] [ Designated as safety issue: No ]
  • Quality of life at baseline, 12 and 24 months post inclusion [ Time Frame: From inclusion (baseline) until relapse or death from any cause or at 12 and 24 months, whichever comes first. ] [ Designated as safety issue: No ]
  • In RICT patients only: Safety and feasibility of the procedure from inclusion to 3 years [ Time Frame: Non-relapse mortality (NRM) and overall survival at two occasions up to 36 months after inclusion. ] [ Designated as safety issue: Yes ]
  • In RICT patients: Incidence & severity of acute and chronic GvHD from transplantation to three years after inclusion [ Time Frame: From transplantation until end of study, up to 36 months after inclusion. ] [ Designated as safety issue: No ]
  • In RICT patients: Rate of complete or partial chimerism from transplant to 3 months [ Time Frame: At Day +100 post Tx ] [ Designated as safety issue: No ]

Estimated Enrollment: 352
Study Start Date: December 2003
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   51 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00342316

Contacts
Contact: Mats Brune, MD, PhD +46 31 342 7349 brune@gu.se
Contact: Thomas Kiss, M.D., FRCPC +1 514 252 3404 thomas.kiss@umontreal.ca

  Show 25 Study Locations
Sponsors and Collaborators
Vastra Gotaland Region
The Canadian Blood and Marrow Transplant Group
Australasian Leukaemia and Lymphoma Group
Investigators
Principal Investigator: Mats Brune, MD, PhD Göteborg University
  More Information

Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT00342316     History of Changes
Other Study ID Numbers: TRALG1/02 
Study First Received: June 20, 2006
Last Updated: January 14, 2016
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Vastra Gotaland Region:
Acute Myeloid Leukemia
Stem Cell Transplantation
Reduced Intensity Conditioning
Survival
Relapse

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 26, 2016