Evaluation of "Dose-dense Therapy" by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML) (AMLCG 2008)

Prof. Dr. Wolfgang Hiddemann

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin

Study type: Interventional

Funder types: Other

Identifiers

NCT01382147

2007-003103-12

Details and patient eligibility

About

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.

Enrollment: 396 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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396 participants in 2 patient groups

S-HAM

Experimental group

Description:

S-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients)

Treatment:

Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin

TAD-HAM (younger) or HAM-HAM (elderly)

Active Comparator group

Description:

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

Treatment:

Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin