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

December 4, 2017 updated by: Prof. Dr. Wolfgang Hiddemann

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bergisch-Gladbach, Germany, 51429
        • Vinzenz-Pallotti-Hospital, Innere Abteilung
      • Berlin, Germany, 13589
        • Evangelisches Waldkrankenhaus Spandau
      • Berlin, Germany, 10115
        • St. Hedwig Krankenhaus, Abteilung Innere Medizin
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukoelln, Innere Medizin - Haematologie und Onkologie
      • Berlin, Germany, 13125
        • HELIOS Klinikum Berlin-Buch, Klinik für Haematologie, Onkologie und Tumorimmunologie
      • Berlin, Germany, 13585
        • Vivantes Klinikum Spandau, Klinik fuer Innere Medizin, Haematologie, Onkologie, Gastroenterologie und Palliativmedizin
      • Bielefeld, Germany, 44791
        • Evangelisches Krankenhaus Bielefeld gGmbH, Klinik fuer Innere Medizin, Haematologie, Onkologie und Palliativmedizin
      • Bochum, Germany, 44791
        • Augusta-Krankenanstalt, Klinik fuer Haematologie, Onkologie und Palliativmedizin
      • Bonn, Germany, 53113
        • Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus, Innere Medizin I
      • Bottrop, Germany, 46242
        • Knappschaftskrankenhaus Bottrop, Klinik fuer Innere Medizin
      • Dortmund, Germany, 44137
        • St.-Johannes Hospital Dortmund, Klinik fuer Innere Medizin II
      • Eschweiler, Germany, 52249
        • St.-Antonius-Hospital Eschweiler, Klinik fuer Haematologie und internistische Onkologie
      • Frankfurt / Oder, Germany, 15236
        • Klinikum Frankfurt / Oder GmbH, Medizinische Klinik I
      • Gelsenkirchen, Germany, 45899
        • St.-Josef-Hospital Gelsenkirchen-Horst, Klinik für Medizinische und Radiologische Onkologie, Hämatologie und Palliativmedizin
      • Gütersloh, Germany, 33332
        • Städtisches Klinikum Gütersloh, Medizinische Klinik II
      • Hagen, Germany, 58095
        • Kath. Krankenhaus Hagen GmbH, Klinik fuer Haematologie und Onkologie
      • Herford, Germany, 32049
        • Klinikum Herford, Medizinische Klinik II
      • Köln, Germany, 50924
        • Universitaetsklinikum Köln, Klinik I fuer Innere Medizin
      • Leverkusen, Germany, 51375
        • Klinikum Leverkusen gGmbH, Medizinische Klinik III
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Medizinische Klinik A
      • Luebbeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein, Medizinische Klinik I, Haematologie / Onkologie
      • Mannheim, Germany, 68167
        • Medizinische Fakultaet Mannheim der Universitaet Heidelberg, III. Medizinische Klinik Haematologie und Internistische Onkologie
      • Merseburg, Germany, 06217
        • Carl-von-Basedow-Klinikum Saalekreis GmbH, Medizinische Klinik II
      • Moenchengladbach, Germany, 41063
        • Krankenhaus Maria Hilf GmbH, Krankenhaus St. Franziskus, Medizinische Klinik I
      • Muenchen, Germany, 81377
        • Klinikum der Universitaet Muenchen Medizinische Klinik und Polikklinik III
      • Muenchen, Germany, 81545
        • Staedtisches Klinikum Harlaching, Klinik für Onkologie und Haematologie
      • Osnabrück, Germany, 49076
        • Klinikum Osnabrück, Klinik fuer Haematologie / Onkologie
      • Paderborn, Germany, 33098
        • Brüderkrankenhaus St. Josef Paderborn, Klinik fuer Haematologie / Onkologie
      • Regensburg, Germany, 93049
        • Krankenhaus Barmherzige Brüder , Klinik fuer internistische Onkologie und Haematologie
      • Siegen, Germany, 57072
        • St.-Marien-Krankenhaus Siegen gem. GmbH, Medizinische Klinik III
      • Wiesbaden, Germany, 65191
        • Stiftung Deutsche Klinik für Diagnostik GmbH, Zentrum fuer Knochenmark- und Stammzelltransplantation
      • Îdar-Oberstein, Germany, 55743
        • Klinikum Idar-Oberstein GmbH, Innere Medizin I, Abteilung Haematologie / Onkologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-HAM
S-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients)
Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
Chemotherapy
Active Comparator: TAD-HAM (younger) or HAM-HAM (elderly)
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
Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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].
Time Frame: 8 years
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Wolfgang Hiddemann

Collaborators

Kompetenznetz Leukämien

Investigators

  • Principal Investigator: Wolfgang Hiddemann, Prof. Dr., Hospital of the University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

July 5, 2017

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-003103-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myeloid Leukemia

Clinical Trials on Ara-C, Mitoxantrone, Daunorubicin, Thioguanin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe