Evaluation of Dose-dense Therapy by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML)

Study Overview
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Brief Summary
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Evaluation weather early chemotherapy attempts for remission induction can improve the results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.

Official Title
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A Randomized, Risk and Age Adapted Comparison of the Dose-Dense Regimen S-HAM (Sequential High Dose Cytosine Arabinoside and Mitoxantrone) Versus Standard Double Induction for Initial Chemotherapy of Adult Patients With Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly diagnosed AML (except acute promyelocytic leukemia) according to the WHO classification including patients with secondary AML and AML after preceding hematologic disorders Age 18 years or older Informed consent. Before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study. Exclusion Criteria: Acute promyelocytic leukemia (APL) Previous or concurrent malignancies other than AML Previous treatment with colony-stimulating factors, interleukins or interferons Known hypersensitivity to Escherichia coli derived products (e.g. Filgrastim, HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®) Antibody-based or cell-based immunotherapies Respiratory insufficiency with pO2 <60 mmHg Heart failure NYHA III° or IV° Elevated creatinine >2.0 mg/dl Elevated bilirubin >2.0 mg/dl Pregnancy or lactation Females 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 truly informed consent for participation in this study Concerns for subject's compliance with the protocol procedures Lack of willingness to record and circulate personal disease-related informations defined in the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-HAM<br>S-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients) | Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin<br>* Chemotherapy<br>|
| Active Comparator: TAD-HAM (younger) or HAM-HAM (elderly)<br>is TAD-9 - HAM for younger patients (with 2 mandatory induction cycles) and HAM (- HAM) for the elderly patients with the second HAM cycle only applied in the case of inadequate blast clearance (> 5%) in the day 16 bone marrow aspirate | Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin<br>* Chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate, aiming at a 15% increase in the CR/PR rate by S-HAM induction versus conventional double induction [TAD - HAM for younger patients, HAM (- HAM) for elderly patients]. |  | 8 years |