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Acute Myeloid LeukemiaPhase 3AMLCG 2008NCT01382147

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

A Phase 3 study testing Ara-C, Mitoxantrone, Daunorubicin, Thioguanin in people with Acute Myeloid Leukemia, run by Prof. Dr. Wolfgang Hiddemann at 32 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
32 sitesGermany
Study dates
1 Jul 2009to 5 Jul 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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 locations and contacts

32 sites in 1 country.

32 sites in 1 country

Germany32 sites

  • Vinzenz-Pallotti-Hospital, Innere Abteilung

    Bergisch Gladbach, 51429

  • St. Hedwig Krankenhaus, Abteilung Innere Medizin

    Berlin, 10115

  • Vivantes Klinikum Neukoelln, Innere Medizin - Haematologie und Onkologie

    Berlin, 12351

  • HELIOS Klinikum Berlin-Buch, Klinik für Haematologie, Onkologie und Tumorimmunologie

    Berlin, 13125

  • Vivantes Klinikum Spandau, Klinik fuer Innere Medizin, Haematologie, Onkologie, Gastroenterologie und Palliativmedizin

    Berlin, 13585

  • Evangelisches Waldkrankenhaus Spandau

    Berlin, 13589

  • Evangelisches Krankenhaus Bielefeld gGmbH, Klinik fuer Innere Medizin, Haematologie, Onkologie und Palliativmedizin

    Bielefeld, 44791

  • Augusta-Krankenanstalt, Klinik fuer Haematologie, Onkologie und Palliativmedizin

    Bochum, 44791

  • Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus, Innere Medizin I

    Bonn, 53113

  • Knappschaftskrankenhaus Bottrop, Klinik fuer Innere Medizin

    Bottrop, 46242

  • Universitaetsklinikum Köln, Klinik I fuer Innere Medizin

    Cologne, 50924

  • St.-Johannes Hospital Dortmund, Klinik fuer Innere Medizin II

    Dortmund, 44137

  • St.-Antonius-Hospital Eschweiler, Klinik fuer Haematologie und internistische Onkologie

    Eschweiler, 52249

  • Klinikum Frankfurt / Oder GmbH, Medizinische Klinik I

    Frankfurt (Oder), 15236

  • St.-Josef-Hospital Gelsenkirchen-Horst, Klinik für Medizinische und Radiologische Onkologie, Hämatologie und Palliativmedizin

    Gelsenkirchen, 45899

  • Städtisches Klinikum Gütersloh, Medizinische Klinik II

    Gütersloh, 33332

  • Kath. Krankenhaus Hagen GmbH, Klinik fuer Haematologie und Onkologie

    Hagen, 58095

  • Klinikum Herford, Medizinische Klinik II

    Herford, 32049

  • Klinikum Idar-Oberstein GmbH, Innere Medizin I, Abteilung Haematologie / Onkologie

    Îdar-Oberstein, 55743

  • Klinikum Leverkusen gGmbH, Medizinische Klinik III

    Leverkusen, 51375

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Medizinische Klinik A

    Ludwigshafen, 67063

  • Universitätsklinikum Schleswig-Holstein, Medizinische Klinik I, Haematologie / Onkologie

    Luebbeck, 23538

  • Medizinische Fakultaet Mannheim der Universitaet Heidelberg, III. Medizinische Klinik Haematologie und Internistische Onkologie

    Mannheim, 68167

  • Carl-von-Basedow-Klinikum Saalekreis GmbH, Medizinische Klinik II

    Merseburg, 06217

  • Krankenhaus Maria Hilf GmbH, Krankenhaus St. Franziskus, Medizinische Klinik I

    Mönchengladbach, 41063

  • Klinikum der Universitaet Muenchen Medizinische Klinik und Polikklinik III

    München, 81377

  • Staedtisches Klinikum Harlaching, Klinik für Onkologie und Haematologie

    München, 81545

  • Klinikum Osnabrück, Klinik fuer Haematologie / Onkologie

    Osnabrück, 49076

  • Brüderkrankenhaus St. Josef Paderborn, Klinik fuer Haematologie / Onkologie

    Paderborn, 33098

  • Krankenhaus Barmherzige Brüder , Klinik fuer internistische Onkologie und Haematologie

    Regensburg, 93049

  • St.-Marien-Krankenhaus Siegen gem. GmbH, Medizinische Klinik III

    Siegen, 57072

  • Stiftung Deutsche Klinik für Diagnostik GmbH, Zentrum fuer Knochenmark- und Stammzelltransplantation

    Wiesbaden, 65191

Other trials in Germany

About this study

Official title: 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.

Being tested
Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ara-C, Mitoxantrone, Daunorubicin, ThioguaninDrug

    Chemotherapy

Study groups in NCT01382147
Study groupRoleWhat they receive
S-HAMExperimentalS-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients)
Receives: Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
TAD-HAM (younger) or HAM-HAM (elderly)Active comparatoris 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
Receives: Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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].

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study start1 Jul 2009
  3. Primary completionAug 2012
  4. Study completion5 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01382147
Sponsor's protocol ID
2007-003103-12
Acronym
AMLCG 2008
Status last verified
Dec 2017
First submitted
23 Jun 2011
Last updated
6 Dec 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Cusan M, Larkin K, Nicolet D, Jurinovic V, Mrozek K, Batcha AMN, Rothenberg-Thurley M, Schneider S, Sauerland C, Gorlich D, Krug U, Berdel WE, Woermann BJ, Hiddemann W, Braess J, Spiekermann K, Greif PA, Blachly JS, Mims AS, Walker CJ, Walker MC, Oakes CC, Orwick S, Carroll AJ, Blum WG, Powell BL, Kolitz JE, Moore JO, Mayer RJ, Larson RA, Stone RM, Byrd JC, Metzeler KH, Herold T, Eisfeld AK. Multi-dimensional analysis of adult acute myeloid leukemia cross-continents reveals age-associated trends in mutational landscape and treatment outcomes (Acute Myeloid Leukemia Cooperative Group & Alliance for Clinical Trials in Oncology). Leukemia. 2025 Dec;39(12):2926-2934. doi: 10.1038/s41375-025-02644-0. Epub 2025 Sep 19.

    PubMed 40973764

  • Archer KJ, Fu H, Mrozek K, Nicolet D, Mims AS, Uy GL, Stock W, Byrd JC, Hiddemann W, Braess J, Spiekermann K, Metzeler KH, Herold T, Eisfeld AK. Identifying long-term survivors and those at higher or lower risk of relapse among patients with cytogenetically normal acute myeloid leukemia using a high-dimensional mixture cure model. J Hematol Oncol. 2024 May 3;17(1):28. doi: 10.1186/s13045-024-01553-6.

    PubMed 38702786

  • Pastore F, Gittinger H, Raab S, Tschuri S, Ksienzyk B, Konstandin NP, Schneider S, Rothenberg-Thurley M, Horny HP, Werner M, Sauerland MC, Amler S, Gorlich D, Berdel WE, Wormann B, Braess J, Hiddemann W, Tischer J, Herold T, Metzeler KH, Spiekermann K. Acute megakaryoblastic leukaemia shows high frequency of chromosome 1q aberrations and dismal outcome. Br J Haematol. 2023 Sep;202(6):1165-1177. doi: 10.1111/bjh.18982. Epub 2023 Jul 16.

    PubMed 37455345

  • Kunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker U, Berdel WE, Muller-Tidow C, Hiddemann W, Serve H, Stelljes M, Baldus CD, Neubauer A, Schetelig J, Thiede C, Bornhauser M, Middeke JM, Stolzel F; A. M. L. Cooperative Group (AMLCG), Study Alliance Leukemia (SAL). Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation. J Hematol Oncol. 2022 Sep 5;15(1):126. doi: 10.1186/s13045-022-01339-8.

    PubMed 36064577

  • Konstandin NP, Pastore F, Herold T, Dufour A, Rothenberg-Thurley M, Hinrichsen T, Ksienzyk B, Tschuri S, Schneider S, Hoster E, Berdel WE, Woermann BJ, Sauerland MC, Braess J, Bohlander SK, Klein HG, Hiddemann W, Metzeler KH, Spiekermann K. Genetic heterogeneity of cytogenetically normal AML with mutations of CEBPA. Blood Adv. 2018 Oct 23;2(20):2724-2731. doi: 10.1182/bloodadvances.2018016840.

    PubMed 30337300

  • Hubmann M, Kohnke T, Hoster E, Schneider S, Dufour A, Zellmeier E, Fiegl M, Braess J, Bohlander SK, Subklewe M, Sauerland MC, Berdel WE, Buchner T, Wormann B, Hiddemann W, Spiekermann K. Molecular response assessment by quantitative real-time polymerase chain reaction after induction therapy in NPM1-mutated patients identifies those at high risk of relapse. Haematologica. 2014 Aug;99(8):1317-25. doi: 10.3324/haematol.2014.104133. Epub 2014 May 9.

    PubMed 24816240

  • Greif PA, Dufour A, Konstandin NP, Ksienzyk B, Zellmeier E, Tizazu B, Sturm J, Benthaus T, Herold T, Yaghmaie M, Dorge P, Hopfner KP, Hauser A, Graf A, Krebs S, Blum H, Kakadia PM, Schneider S, Hoster E, Schneider F, Stanulla M, Braess J, Sauerland MC, Berdel WE, Buchner T, Woermann BJ, Hiddemann W, Spiekermann K, Bohlander SK. GATA2 zinc finger 1 mutations associated with biallelic CEBPA mutations define a unique genetic entity of acute myeloid leukemia. Blood. 2012 Jul 12;120(2):395-403. doi: 10.1182/blood-2012-01-403220. Epub 2012 May 30.

    PubMed 22649106

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ara-C, Mitoxantrone, Daunorubicin, Thioguanin in people with Acute Myeloid Leukemia, run by Prof. Dr. Wolfgang Hiddemann at 32 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01382147, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.

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