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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Göteborg University
Sponsor:
Collaborators:
Swedish Cancer Foundation
Nordic Cancer Union
The Canadian Blood and Marrow Transplant Group
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT00342316
First received: June 20, 2006
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

This study compares overall survival between patients with acute myeloid leukemia, who are in complete remission (ie all signs of disease have disappeared) following initial treatment with chemotherapy and whose remission is maintained either with a transplantation of stem cells obtained from a sibling donor or with standard treatment, which is additional chemotherapy without a stem cell transplant from a donor.

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: 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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

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 6, 12, 24, 36 months post inclusion [ Time Frame: From inclusion until relapse or death from any cause or at 6, 12, 24 and 36 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 1, 2 months and Day +100 ] [ Designated as safety issue: No ]
  • In RICT patients: Safety and efficacy of DLI for relapse or MRD from transplant to 3 years [ Time Frame: From transplantation until end of study, up to 36 months after inclusion. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 352
Study Start Date: December 2003
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2013 (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
  • At least one sibling willing to undergo HLA-typing

Exclusion Criteria:

  • Planned for a full-dose allogeneic transplant
  • Planned for a transplant from an unrelated donor
  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@medfak.gu.se
Contact: Bo I Nilsson, MD, PhD +46 42 242264 bo.nilsson@connector-medical.com

Locations
Canada, Manitoba
Cancer Care Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Christopher Bredeson, M.D.         
Contact: Jamie Vaughn, R.N.         
Principal Investigator: Christopher Bredeson, M.D.         
Sub-Investigator: Matthew Sheftel, M.D.         
Canada, Ontario
McMaster Site Ward 3Z, Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Irwin Walker, M.D.       walkeri@mcmaster.ca   
Contact: Tammy DeGelder, R.N.         
Principal Investigator: Irwin Walker, M.D.         
Hematology, Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Mitchell Sabloff, M.D.         
Contact: Nathalie Vrana, R.N.         
Principal Investigator: Mitchell Sabloff, M.D.         
Canada, Quebec
Hématologie, Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Thomas Kiss, MD    +1 514 252 3404    thomas.kiss@umontreal.ca   
Contact: Francine Habel, RN         
Principal Investigator: Thomas Kiss, MD         
Hematology, Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Ahmad Galal, M.D.         
Contact: Nancy Hutchison, R.N.         
Principal Investigator: Ahmad Galal, M.D.         
Canada
Hématologie, Hospital CHA Enfant-Jésus Recruiting
Quebec, Canada, G1J 1Z4
Contact: Robert Delage, M.D.       r.delage@videotron.ca   
Contact: Jaqueline Poulin, R.N.       jacqueline.poulin@cha.quebec.qc.ca   
Principal Investigator: Robert Delage, M.D.         
Germany
Dept of Hematology, University Hospital Recruiting
Freiburg, Germany, 79106
Contact: Jürgen Finke, MD, PhD    +49 761 270 3679    finke@mm11.ukl.uni-freiburg.de   
Principal Investigator: Jürgen Finke, MD, PhD         
Israel
Hematology Division, Chaim Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Arnon Nagler, MD, MSc    +972 3 530 5830    a.nagler@sheba.health.gov.il   
Principal Investigator: Arnon Nagler, MD, MSc         
Norway
Section of Hematology, National Hospital Recruiting
Oslo, Norway, 0027
Contact: Lorentz Brinch, MD, PhD    +47 2307 0000    lorentz.brinch@rigshospitalet.no   
Principal Investigator: Lorentz Brinch, MD, PhD         
Sweden
Department of Hematology, Sahlgrenska University Hospital Recruiting
Goteborg, Sweden, 41345
Contact: Mats Brune, MD, PhD    +46 31 342 7349    brune@medfak.gu.se   
Contact: Elisabeth Wallhult, RN    +46 31 342 8408    elisabeth.wallhult@vgregion.se   
Principal Investigator: Mats Brune, M.D., Ph.D.         
Sponsors and Collaborators
Göteborg University
Swedish Cancer Foundation
Nordic Cancer Union
The Canadian Blood and Marrow Transplant Group
Investigators
Study Chair: Mats Brune, MD, PhD University of Goteborg
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT00342316     History of Changes
Other Study ID Numbers: TRALG1/02
Study First Received: June 20, 2006
Last Updated: March 26, 2013
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Göteborg University:
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 November 20, 2014