Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Acute Myeloid Leukemia, Stem Cell Transplantation, Reduced Intensity Conditioning, Survival, Relapse
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Reduced Intensity Conditioning Stem Cell Transplantation
Type: Procedure
Overall Status
Recruiting
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.
Detailed Description
Objectives:

The primary objective of this study is to determine whether RICT leads to an improved overall survival at three years compared to conventional treatment for AML.

The secondary objectives of this study are to determine if:

- RICT leads to a superior long-term overall survival compared to conventional therapy.

- RICT leads to a superior disease-free survival compared to conventional therapy.

- Time to relapse is different between RICT and control groups.

- Quality of life is different between the two treatment groups.

- in RICT patients only:

- Safety and feasibility of the procedure

- Incidence and severity of acute and chronic Graft versus Host Disease

- Rate of complete and partial chimerism

- Safety and efficacy of donor lymphocyte infusions for relapse or minimal residual disease.

Study Population:

- Newly diagnosed patients with de novo or secondary AML, intermediate or poor risk, in first complete remission aged 51-70 years.

- Not planned for a full-dose allogeneic transplant.

- According to the investigator, fit for a RICT if a suitable donor is found, and also fit for further consolidation chemotherapy in case no suitable donor is found.

Procedures:

Patients will receive induction therapy according to institutional practice and can be included after achieving complete remission following induction course(s). Patients for whom a full-dose conditioned allogeneic transplantation is planned will not be approached, neither will patients who are who are for for other reasons judged to be ineligible for a RICT. Eligible patients will be informed about the study. After the patient's consent has been obtained, potential sibling donor(s) will be briefly informed about the study and asked if they are willing to undergo HLA-typing. Siblings with evident contraindications to G-CSF or collection of peripheral blood stem cells should not proceed to HLA-typing. A search for an unrelated matched donor (MUD) will be initiated if there are no potential sibling donor, or if sibs are not HLA-identical or otherwise not fit for the donation procedure.

- A patient's inclusion in the study is when blood sampling for tissue typing (HLA-typing) of the first potential sibling donor is made, or when a search warrant for a MUD is dispatched.

Included patients with a HLA-identical sibling or with an identified MUD will be assigned to the RICT group, and included patients without such a donor will automatically be in the control group. This is a HLA-based assignment, and the final intent-to-treat analysis will be based on the treatment assignment.

After treatment assignment, patients on the control arm should receive consolidation therapy as per institutional practice, whereas patients on the RICT arm may proceed directly to RICT or receive one or maximum two consolidation courses. Patients should be in complete remission at the time of transplant. All patients will be followed for relapse and survival for a period of at least three years.

The inclusion of 352 patients in complete remission - 88 patients in the RICT group and 264 in the control group - provides a statistical power of 90 % to detect a difference in overall survival at three years of 20 percentage points, ie from 30 % of control patients to 50 % in RICT patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 51 Years
Gender: Both
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
Locations
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Status: Recruiting
Contact: Christopher Bredeson, M.D.
McMaster Site Ward 3Z, Hamilton Health Sciences
Hamilton, Ontario, Canada
Status: Recruiting
Contact: Irwin Walker, M.D. - walkeri@mcmaster.ca
Hematology, Ottawa Hospital
Ottawa, Ontario, Canada
Status: Recruiting
Contact: Mitchell Sabloff, M.D.
Hematology, Royal Victoria Hospital
Montreal, Quebec, Canada
Status: Recruiting
Contact: Ahmad Galal, M.D.
Hématologie, Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Status: Recruiting
Contact: Thomas Kiss, MD - +1 514 252 3404 - thomas.kiss@umontreal.ca
Hématologie, Hospital CHA Enfant-Jésus
Quebec, Canada
Status: Recruiting
Contact: Robert Delage, M.D. - r.delage@videotron.ca
Dept of Hematology, University Hospital
Freiburg, Germany
Status: Recruiting
Contact: Jürgen Finke, MD, PhD - +49 761 270 3679 - finke@mm11.ukl.uni-freiburg.de
Section of Hematology, National Hospital
Oslo, Norway
Status: Recruiting
Contact: Lorentz Brinch, MD, PhD - +47 2307 0000 - lorentz.brinch@rigshospitalet.no
Department of Hematology, Sahlgrenska University Hospital
Goteborg, Sweden
Status: Recruiting
Contact: Mats Brune, MD, PhD - +46 31 342 7349 - brune@medfak.gu.se
Start Date
December 2003
Completion Date
March 2016
Sponsors
Vastra Gotaland Region
Source
Vastra Gotaland Region
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page