Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result
Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
Participant gender:
Summary
The concept of the investigators risk-adapted multicenter treatment trial for younger adults,
AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of
risk groups is different compared to the AML HD93 trial; high-risk: refractory disease after
first induction therapy and/or high risk karyotype [abn(3q), -5/5q-, -7/7q-, abn(12p),
abn(17p), complex]; intermediate-risk: complete remission after induction therapy and
intermediate risk karyotype [normal, abn(11q23), abn(16q22), other rare aberrations];
low-risk: complete remission after induction therapy and low risk karyotype [t(8;21)].
Patients exhibiting a t(15;17) were treated in a separated trial (APL HD95). Treatment
consists of a first induction therapy with ICE followed by a second cycle ICE in case of
response to first induction therapy. Patients with refractory disease after first induction
therapy are assigned to a salvage therapy with A-HAM (all-trans retinoic acid, high-dose
cytarabine and mitoxantrone) and the search for potential hematopoietic stem cell donors is
extended from the family to unrelated persons. All patients achieving a CR after induction
therapy with ICE are assigned to a first consolidation therapy with HAM. For
intermediate-risk patients a peripheral stem cell or a bone marrow harvest are intended
during the hematological recovery after the first consolidation. Second consolidation therapy
was stratified according to the risk definition. For high risk patients a allogeneic
transplantation is assigned from a related or unrelated donor preferentially after a
dose-intensified conditioning therapy. All patients with intermediate risk and an HLA-matched
family donor are assigned to allogeneic transplantation. Intermediate-risk patients without a
family donor and normal karyotype at diagnosis are randomized between an autologous stem cell
transplantation and a second course of HAM. The other intermediate-risk patients are assigned
to autologous transplantation. For low-risk patients a second course of HAM is assigned.