HCT Versus CT in Elderly AML

This study is not yet open for participant recruitment.

Verified by European Group for Blood and Marrow Transplantation, October 2008

Sponsors and Collaborators:	European Group for Blood and Marrow Transplantation ALFA: Acute Leukemia French Association CETLAM: Grupo Cooperativo para el Estudio y Tratamiento de las Leucemias agudas y Mielodisplasias EORTC: European Organisation for Research and Treatment of Cancer GOELAMS: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang HOVON - Dutch Haemato-Oncology Association OSHO: East German Study Group of Hematology and Oncology Swiss Group for Clinical Cancer Research
Information provided by:	European Group for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier:	NCT00766779

Purpose

A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

Condition	Intervention	Phase
Acute Myeloid Leukemia	Procedure: hematopoietic cell transplantation Drug: Non-Transplant treatment approach for consolidation	Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission

Further study details as provided by European Group for Blood and Marrow Transplantation:

Primary Outcome Measures:

To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	218
Study Start Date:	December 2008
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Transplant Arm: Experimental Hematopoietic cell transplantation after Reduced Intensity Conditioning	Procedure: hematopoietic cell transplantation low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors
Conventional Chemotherapy: Active Comparator The non-transplant treatment approach for consolidation	Drug: Non-Transplant treatment approach for consolidation Patients will receive the treatment that would be otherwise applied at the local institution. The consolidation or maintenance therapy is according to the study group protocol.

Detailed Description:

The majority of patients with acute myelogenous leukaemia (AML) enter complete remission following induction therapy, but relapse despite consolidation and maintenance therapy. In response, post-remission treatment has been progressively intensified and results improved either by high-dose post-remission therapy with autologous hematopoietic cell transplantation (HCT) or by allogeneic HCT, which has the highest curative potential for patients with AML. Given the toxicity of dose intensification and of allogeneic HCT, however, only younger patients profit from this treatment approach

Eligibility

Ages Eligible for Study:	60 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 60years and ≤ 75 years
AML as defined by WHO
Refractory anaemia with excess of blasts (RAEB)
primary and secondary AML
First complete remission following one or two cycles of induction chemotherapy, according to current participating cooperative group protocols
Karnofsky score ≥ 70 (see appendix D)
Written informed consent

Exclusion Criteria:

AML FAB M3
Organ dysfunction
Patients with creatinine clearance < 50 ml/min
Cardiac ejection fraction < 40%
Severe defects in pulmonary function testing (defects are currently categorized as mild, moderate and severe) as defined by the pulmonary consultant, or receiving supplementary continuous oxygen
Liver function tests: total bilirubin > 2x the upper limit of normal, SGOT and SGPT 4x the upper limit of normal
Karnofsky score < 70 (see appendix D)
Patients with poorly controlled hypertension
HIV positivity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766779

Contacts

Contact: Ruzena B Uddin	00442071888598	ruzena.uddin@kcl.ac.uk
Contact: Kim Champion	00442071888402	kim.champion@kcl.ac.uk

Locations

France
Hospital Saint-Louis
Paris, France, 75010
Institut Paoli Calmettes
Marseille, France, 12373
Germany
University Hospital
Leipzig, Germany, 04103
Italy
Universita di Roma Tor Vergata
Rome, Italy, 00133
Netherlands
Erasmus MC-Daniel den Hoed Cancer Centre
Rotterdam, Netherlands, 3008
Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Switzerland
University Hospital
Basel, Switzerland, 4031
Hopitaux Universitaires de Geneve
Geneve, Switzerland, 1211

Sponsors and Collaborators

European Group for Blood and Marrow Transplantation

ALFA: Acute Leukemia French Association

CETLAM: Grupo Cooperativo para el Estudio y Tratamiento de las Leucemias agudas y Mielodisplasias

EORTC: European Organisation for Research and Treatment of Cancer

GOELAMS: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang

HOVON - Dutch Haemato-Oncology Association

OSHO: East German Study Group of Hematology and Oncology

Swiss Group for Clinical Cancer Research

Investigators

Study Chair:	Dietger Niederwieser, Prof	EBMT and OSHO
Study Chair:	Bob Löwenberg, Prof	HOVON

More Information

Responsible Party:	EBMT ( Prof Dietger Niederwieser )
Study ID Numbers:	2007-003514-34, EBMT-ALWP01/2008
Study First Received:	October 3, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00766779
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic

Keywords provided by European Group for Blood and Marrow Transplantation:

hematopoietic cell transplantation
Acute Myeloid Leukemia
first Complete Remission

Study placed in the following topic categories:

Leukemia
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009