NCT01382147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_3

Geographic Reach
1 country

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2017

Completed
Last Updated

December 6, 2017

Status Verified

December 1, 2017

Enrollment Period

3.1 years

First QC Date

June 23, 2011

Last Update Submit

December 4, 2017

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (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].

    8 years

Study Arms (2)

S-HAM

EXPERIMENTAL

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

Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin

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

ACTIVE COMPARATOR

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

Interventions

Ara-C, Mitoxantrone, Daunorubicin, ThioguaninDRUG

Chemotherapy

S-HAMTAD-HAM (younger) or HAM-HAM (elderly)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Vinzenz-Pallotti-Hospital, Innere Abteilung

Bergisch Gladbach, 51429, Germany

Location

St. Hedwig Krankenhaus, Abteilung Innere Medizin

Berlin, 10115, Germany

Location

Vivantes Klinikum Neukoelln, Innere Medizin - Haematologie und Onkologie

Berlin, 12351, Germany

Location

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

Berlin, 13125, Germany

Location

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

Berlin, 13585, Germany

Location

Evangelisches Waldkrankenhaus Spandau

Berlin, 13589, Germany

Location

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

Bielefeld, 44791, Germany

Location

Augusta-Krankenanstalt, Klinik fuer Haematologie, Onkologie und Palliativmedizin

Bochum, 44791, Germany

Location

Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus, Innere Medizin I

Bonn, 53113, Germany

Location

Knappschaftskrankenhaus Bottrop, Klinik fuer Innere Medizin

Bottrop, 46242, Germany

Location

Universitaetsklinikum Köln, Klinik I fuer Innere Medizin

Cologne, 50924, Germany

Location

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

Dortmund, 44137, Germany

Location

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

Eschweiler, 52249, Germany

Location

Klinikum Frankfurt / Oder GmbH, Medizinische Klinik I

Frankfurt (Oder), 15236, Germany

Location

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

Gelsenkirchen, 45899, Germany

Location

Städtisches Klinikum Gütersloh, Medizinische Klinik II

Gütersloh, 33332, Germany

Location

Kath. Krankenhaus Hagen GmbH, Klinik fuer Haematologie und Onkologie

Hagen, 58095, Germany

Location

Klinikum Herford, Medizinische Klinik II

Herford, 32049, Germany

Location

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

Îdar-Oberstein, 55743, Germany

Location

Klinikum Leverkusen gGmbH, Medizinische Klinik III

Leverkusen, 51375, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Medizinische Klinik A

Ludwigshafen, 67063, Germany

Location

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

Luebbeck, 23538, Germany

Location

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

Mannheim, 68167, Germany

Location

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

Merseburg, 06217, Germany

Location

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

Mönchengladbach, 41063, Germany

Location

Klinikum der Universitaet Muenchen Medizinische Klinik und Polikklinik III

München, 81377, Germany

Location

Staedtisches Klinikum Harlaching, Klinik für Onkologie und Haematologie

München, 81545, Germany

Location

Klinikum Osnabrück, Klinik fuer Haematologie / Onkologie

Osnabrück, 49076, Germany

Location

Brüderkrankenhaus St. Josef Paderborn, Klinik fuer Haematologie / Onkologie

Paderborn, 33098, Germany

Location

Krankenhaus Barmherzige Brüder , Klinik fuer internistische Onkologie und Haematologie

Regensburg, 93049, Germany

Location

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

Siegen, 57072, Germany

Location

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

Wiesbaden, 65191, Germany

Location

Related Publications (6)

  • 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.

    PMID: 38702786DERIVED

  • 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.

    PMID: 37455345DERIVED

  • 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.

    PMID: 36064577DERIVED

  • 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.

    PMID: 30337300DERIVED

  • 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.

    PMID: 24816240DERIVED

  • 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.

    PMID: 22649106DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

CytarabineMitoxantroneDaunorubicin

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic CompoundsAnthracyclinesNaphthacenesAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Wolfgang Hiddemann, Prof. Dr.

    Hospital of the University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the Department of Medicine III

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 27, 2011

Study Start

July 1, 2009

Primary Completion

August 1, 2012

Study Completion

July 5, 2017

Last Updated

December 6, 2017

Record last verified: 2017-12

Locations

DE(32)