HCT Versus CT in Elderly AML

• Status: Terminated
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Trials; European Society for Blood and Marrow Transplantation
• Collaborators: 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

Criteria

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