Main info

Identifier:

HO42(A) AML

Sponsor:

HOVON

Working group party:

Leukemia

Age:

18-60

Stage:

1st Line

Echelon:

Limited Site Selection

Included patients:

518

(of 1440)

Active sites:

37

(of 39)

1 sites are pending

Title:

Randomized induction and post induction therapy in adult patients (<=60 yrs of age) with acute myelocytic leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t) with IPSS score >= 1.5

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Not any more

Objectives:

• To study in a randomized comparison the use of granulocyte-colony stimulating factor (GCSF) for priming during induction cycles I and II as regards the complete remission rate, disease free survival, risk of relapse and overall survival.
• To evaluate the outcome of allogeneic sibling SCT in intermediate risk patients and compare the results with those after chemotherapy and ablation + PBSCT
• To assess the value of early allogeneic family donor and unrelated donor SCT in patients with poor risk AML in comparison to the results in those treated with chemotherapy and ablation + PBSCT
• To determine the prognostic value of molecular markers and gene expression profiles of the leukemia assessed at diagnosis
• To assess minimal residual disease following therapy by standardized sampling of marrow/blood

Eligibility

Inclusion Criteria:

• Age 18-60 years (incl.)
• Subjects with a cytopathologically confirmed diagnosis of
  • AML (M0-M2 and M4-M7, FAB classification, appendix A), or
  • with refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >1.5 (appendix B)
• Patients with therapy-related AML/RAEB/RAEB-t are eligible provided they have not received chemotherapy during the past 6 months. Also patients with biphenotypic leukemia may be included.
• Subjects with a secondary AML progressing from antecedent myelodysplasia are eligible. Antecedent MDS refers to a condition of at least 4 month duration
• WHO performance status ≤ 2 (see appendix E)
• Written informed consent

Exclusion Criteria:

• Prior chemotherapy within 6 months of study entry
• Relapse of AML or MDS after induction chemotherapy
• Prior stem cell transplant
• Previous polycythemia rubra vera
• Primary myelofibrosis
• Blast crisis of chronic myeloid leukemia
• AML-FAB type M3 or AML with cytogenetic abnormality t(15;17) or AML with a PML/RAR alpha or a variant RAR alpha fusion gene
• Impaired hepatic or renal function as defined by:
  • ALT and/or AST > 3 x normal value
  • Bilirubin > 3 x normal value
  • Serum creatinin > 3 x normal value (after adequate hydration), (unless these are most likely caused by AML organ infiltration)
• Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.)
• Cardiac dysfunction as defined by:
  • Myocardial infarction within the last 6 months of study entry, or
  • Reduced left ventricular function with an ejection fraction <50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable)
  • Unstable angina
  • Unstable cardiac arrhythmias
• Pregnancy

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals