HCT Versus CT in Elderly AML

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00766779
• Other study ID #: 2007-003514-34
• Secondary ID: EBMT-ALWP01/2008
• Status: Terminated
• Phase: Phase 3
• Start date: January 2010
• Est. completion date: December 2020

Study information

• Verified date: October 2021
• Source: European Society for Blood and Marrow Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age = 60years and = 75 years
• primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
• First complete remission following one or two cycles of induction chemotherapy
• Chemotherapy was administered according to current participating cooperative group protocols
• Karnofsky score = 70
• Written informed consent

Exclusion Criteria:

• AML FAB M3
• HIV positivity
• Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
• The second study exclusively concerns induction therapy
• Consolidation cycle one and two are given according to the accredited study group policy
• No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
• Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Procedure:
• hematopoietic cell transplantation
low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors

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.

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne Victoria
Austria	Hanusch Krankenhaus der Wiener Gebietskrankenkasse	Wien
Austria	Medizinische Universität Wien	Wien
Belgium	ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen	Antwerpen
Belgium	UZ Gasthuisberg Leuven	Leuven
France	Centre Hospitalier Sud Amiens	Amiens cedex 1
France	Hopital Femme Enfant Hématologie	Caen Cedex 9
France	Hôpital d'instruction des armées Percy	Clamart
France	Centre hospitalier et universitaire (CHU) d´ Estaing	Clermont-Ferrand
France	Centre hospitalier et universitaire (CHU) de Limoges	Limoges cedex
France	Institut Paoli-Calmettes	Marseille cedex 9
France	CHU de Nantes, Hôtel Dieu	Nantes cedex 01
France	Centre hospitalier et universitaire (CHU) de Nice	Nice
France	Centre Antoine Lacassagne	Nice cedex 2
France	Hopital Saint Antoine	Paris 12ème
France	CHU du Haut Lévêque	Pessac
France	Centre Hospitalier (CH) Saint Quentin	Saint Quentin cedex
Germany	University Aachen	Aachen
Germany	II. Medizinische Klinik, Hämatologie/Internistische Onkologie	Augsburg
Germany	Charité - Campus Benjamin Franklin	Berlin
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Universitaetsklinikum Dresden	Dresden
Germany	Klinik für Innere Medizin C	Greifswald
Germany	University of Heidelberg	Heidelberg
Germany	Friedrich-Schiller-Universität Jena	Jena
Germany	University Hospital	Leipzig
Germany	Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität	Magdeburg
Germany	University of Münster	Münster
Germany	Klinikum Ernst von Bergmann gGmbH	Potsdam
Germany	University Regensburg	Regensburg
Germany	Universität Rostock	Rostock
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Germany	Universität Tübingen	Tübingen
Germany	Allogeneic Stem Cell Transplant Cente	Würzburg
Netherlands	Academisch Ziekenhuis bij de Universiteit Amsterdam	Amsterdam
Netherlands	VU University Medical Center Amsterdam	Amsterdam
Netherlands	University Medical Centre Groningen	Groningen
Netherlands	University Hospital Maastricht	Maastricht
Netherlands	Erasmus MC-Daniel den Hoed Cancer Centre	Rotterdam
Netherlands	University Medical Centre Utrecht	Utrecht
Netherlands	Isala klinieken	Zwolle
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	University Hospital	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	Hopitaux Universitaires de Geneve	Geneve
Switzerland	CHUV Lausanne	Lausanne
Switzerland	Kantonsspital Luzern	Luzern 16
Switzerland	University Hospital Zürich	Zürich

Sponsors (8)

Lead Sponsor	Collaborator
European Society for Blood and Marrow Transplantation	Acute Leukemia French Association, East German Study Group of Hematology and Oncology (OSHO), European Organisation for Research and Treatment of Cancer - EORTC, French Innovative Leukemia Organisation, Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias, HOVON - Dutch Haemato-Oncology Association, Swiss Group for Clinical Cancer Research

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  France,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		5 years
Secondary	To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT		5 Years