Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia
This study is currently recruiting participants.
Verified March 2013 by Göteborg University
Sponsor:
Göteborg University
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
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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:
|
|
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
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, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013