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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
396

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Wolfgang Hiddemann

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kompetenznetz Leukämien

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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