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

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.

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

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