Adult patients (=18 years) with newly-diagnosed acute myeloid leukemia (AML) - except acute promyelocytic leukemia (APL) and t(15
Conditions
Interventions
Product Name: Cytarabine (AraC)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Cytarabine
CAS Number: 147-94-4
Current Sponsor code: Cytarabine (AraC)
Concentration unit: gm/m2 gra
Sponsors
Hospital of the University of Munich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with newly diagnosed AML (except acute promyelocytic leukemia and t(15;17)) according to the WHO classification • Age =18 years • Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Acute promyelocytic leukemia (APL) and t(15;17) • Concurrent malignancies other than AML except carcinoma in situ or basalioma • Elderly patients [= 60 (- 70) years], i.e. those who are deemed unfit for allogenic transplantation, with complex karyotypes • Known hypersensitivity to Escherichia coli derived products (e.g. Filgrastim, HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®) • Concurrent antibody-based or cell-based immunotherapies • Respiratory insufficiency with pO2 2.0 mg/dl) within the 7 days prior to study entry* unless caused by the AML • Permanently elevated bilirubin (>2.0 mg/dl) within the 7 days prior to study entry* unless caused by the AML • Pregnancy or breastfeeding (pregnancy test to be performed prior to study entry*) • Patients without adequate contraception** • Known HIV and/or hepatitis C infection • Severe neurologic or psychiatric disease • Psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study • Simultaneous participation in the active intervention phase of another investigational or drug trial on antileucemic therapy • Concerns for subject’s compliance with the protocol procedures Notes: *: Study entry is defined as date of written informed consent. **: All patients are to be advised that they must use a safe method of contraception during the course of the study and for a minimum of 6 months after completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall response rate (ORR), aiming at a 15% increase in the CR (complete remission)/CRi (incomplete peripheral recovery) rate by S-HAM induction versus conventional double induction [TAD – HAM for younger patients, HAM (- HAM) for elderly patients].;Secondary Objective: • Duration of critical neutropenia and hospitalization • Event free, relapse free and overall survival • Remission duration • Treatment associated side effects;Primary end point(s): Overall response rate (ORR) after induction therapy in patients with newly diagnosed acute myeloid leukemia (AML). ORR comprises complete remission (CR) and CR with incomplete peripheral recovery (CRi). | — |
Countries
Germany
Outcome results
None listed