NCT00766779

HCT Versus CT in Elderly AML

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: European Society for Blood and Marrow Transplantation · Network
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2008-10-06
• Last updated: 2021-10-14

Locations

48 sites across 7 countries: Australia, Austria, Belgium, France, Germany, Netherlands, Switzerland