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

NCT00342316 | Completed DMC

• 1 other identifier: TRALG1/02
• Study Type: interventional
• Target: 340
• Locations: 9 countries
• Sites: 25

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Stem Cell Transplantation; Reduced Intensity Conditioning; Survival; Relapse

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS is the time from Inclusion to death, lost to follow-up, refusal, or study termination.

  From Inclusion until one of the above events (≥2yrs in all surviving pts).

Secondary Outcomes (4)

• Disease-free survival

  From Inclusion to relapse, death or study termination. Follow-up ≥24 mo in all surviving pts.

• Quality of Life for pts in the RICT and Control Groups.

  All pts were asked to fill out the instrument at 12 and 24 months after inclusion

• Non-relapse mortality (NRM). Numbers and causes of death in non-relapsed pts

  From Inclusion to relapse or death until study termination.

• Acute and Chronic Graft-versus-Host Disease (GvHD)

  Acute GvHD: From transplant to 3 months. Chronic From transplantation to relapse, death or study termination

Study Arms (2)

Stem cell transplant (RICT)

EXPERIMENTAL

Receiving intervention consisting of Reduced Intensity Conditioning Stem Cell Transplantation

Procedure: Reduced Intensity Conditioning Stem Cell Transplantation

Control arm

NO INTERVENTION

Treatment according to standard of care, i.e. not undergoing RICT

Interventions

Reduced Intensity Conditioning Stem Cell Transplantation PROCEDURE

One of the following conditioning regimens: 1. Busulphan (orally or IV), fludarabine 2. Fludarabine, carmustine, melfalan 3. Cyclophosphamide, fludarabine

Stem cell transplant (RICT)

Eligibility Criteria

• Age: 51 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Planned for a full-dose allogeneic transplant

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• The Canadian Blood and Marrow Transplant Group: collaborator
• Australasian Leukaemia and Lymphoma Group: collaborator

Study Sites (25)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Austalasian Leukaemia &Lymphoma Group Limited

East Melbourne, Victoria, 3002, Australia

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

McMaster Site Ward 3Z, Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hematology, Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Hématologie, Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Hematology, Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Hématologie, Hospital CHA Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

L'Hôtel Dieu de Quebec

Québec, Quebec, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Tartu University Hospital

Tartu, 51014, Estonia

Location

Turku University Hospital

Turku, 20520, Finland

Location

Dept of Hematology, University Hospital

Freiburg im Breisgau, 79106, Germany

Location

University Hospital of Patras

Pátrai, 26504, Greece

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Wellington Hospital

Wellington, 6021, New Zealand

Location

Section of Hematology, National Hospital

Oslo, 0027, Norway

Location

Department of Hematology, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Sunderby Hospital

Luleå, Sweden

Location

Skåne University Hospital Lund

Lund, Sweden

Location

University Hospital Örebro

Örebro, Sweden

Location

Karolinska University Hospital Huddinge

Stockholm, Sweden

Location

Karolinska University Hospital Solna

Stockholm, Sweden

Location

Uppsala Akademiska Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mats Brune, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 20, 2006
• First Posted: June 21, 2006
• Study Start: December 18, 2003
• Primary Completion: July 5, 2018
• Study Completion: July 20, 2018
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8); NO (1); SE (7); GR (1); AU (3); ES (1); FI (1); DE (1); NZ (2)