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

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin

• Registration Number: NCT01382147
• Lead Sponsor: Prof. Dr. Wolfgang Hiddemann

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-01
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Primary Completion: 2012-08
• Study Completion: 2017-07-05
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAD-HAM (younger) or HAM-HAM (elderly)	Ara-C, Mitoxantrone, Daunorubicin, Thioguanin	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
S-HAM	Ara-C, Mitoxantrone, Daunorubicin, Thioguanin	S-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (32)

Vinzenz-Pallotti-Hospital, Innere Abteilung; 🇩🇪 Bergisch-Gladbach, Germany

St. Hedwig Krankenhaus, Abteilung Innere Medizin; 🇩🇪 Berlin, Germany

Vivantes Klinikum Neukoelln, Innere Medizin - Haematologie und Onkologie; 🇩🇪 Berlin, Germany

HELIOS Klinikum Berlin-Buch, Klinik für Haematologie, Onkologie und Tumorimmunologie; 🇩🇪 Berlin, Germany

Vivantes Klinikum Spandau, Klinik fuer Innere Medizin, Haematologie, Onkologie, Gastroenterologie und Palliativmedizin; 🇩🇪 Berlin, Germany

Evangelisches Waldkrankenhaus Spandau; 🇩🇪 Berlin, Germany

Evangelisches Krankenhaus Bielefeld gGmbH, Klinik fuer Innere Medizin, Haematologie, Onkologie und Palliativmedizin; 🇩🇪 Bielefeld, Germany

Augusta-Krankenanstalt, Klinik fuer Haematologie, Onkologie und Palliativmedizin; 🇩🇪 Bochum, Germany

Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus, Innere Medizin I; 🇩🇪 Bonn, Germany

Knappschaftskrankenhaus Bottrop, Klinik fuer Innere Medizin; 🇩🇪 Bottrop, Germany

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