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Biology and Treatment Strategy of AML in Its Subgroups: Multicenter Randomized Trial by the German Acute Myeloid Leukemia Cooperative Group (AMLCG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00266136
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : October 26, 2012
Deutsche Krebshilfe e.V., Bonn (Germany)
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Prof. Dr. Thomas Büchner, University Hospital Muenster

Brief Summary:
The study in patients with primary and secondary AML and high-risk MDS uses a risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of G-CSF priming, and of autologous stem cell transplantation.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Cytarabine Drug: Thioguanine Drug: Daunorubicin Drug: Cyclophosphamide Drug: G-CSF Procedure: Autologous stem cell transplantation Procedure: Allogeneic stem cell transplantation Phase 3

Detailed Description:

The present study by the German AML Cooperative Group has been designed in order to investigate the effects of AML typical therapeutic strategies for AML and related diseases. Thus, the entry criteria are age starting from 16 years with no upper age limit, de novo AML or AML secondary to chemotherapy or radiotherapy of another disease or myelodysplasia subtype RAEB with bone marrow blasts greater than 10 %. All randomization is stratified according to karyotype favorable / intermediate / unfavorable. Additional stratification is according to LDH </>= 700 U and age </>= 60 Y. Standard treatment is (A) double induction with TAD and HAM, consolidation with TAD and maintenance treatment with monthly AD-AT-AC-AT -, rotatingly. Experimental modifications to be compared with stan-dard treatment are (B) double induction with HAM-HAM, (C) multiple course G-CSF before and during chemotherapy courses and (D) instead of maintenance treatment myeloablative consolidation with Bu/Cy and autologous blood stem cell transplantation. Intent to treat conditions are guaranteed by randomization before induction treatment starts. In order to evaluate the effect of every single modification randomization to (C) is equally distributed to the patients in treatment arms (A) and (B) which is also true for the randomization to (D) (balanced randomization). Similarly balanced between treatment arms are the patients according to diagnosis, age and risk factors like serum LDH and karyotype. In order to adapt treatment intensity to age patients of 60 years and older receive the second induction course only in case of 5 % or more residual bone marrow blasts. In addition, the AraC dose in HAM is reduced to 1 instead of 3 g/sqm in this age group. Furthermore, there is no treatment arm including stem cell transplantation in patients of 60+ years. Pri-mary endpoint to compare the therapeutic strategies is event-free survival from treatment start (A, B, C) and from achievement of remission (D), respectively.

By this design the AMLCG 2000 trial can contribute relevant experiences on optimum therapeutic strategies for the biological subgroups of de novo AML, secondary AML and MDS. Furthermore, new biological subgroups and their significance related to treatment strategies can be defined.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3500 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risk-stratified Therapy for Primary and Secondary AML and MDS. A Randomized Study by AMLCG in Relation to Cytogenetically Defined Prognostic Factors (1) on the Role of High-dose AraC as Part of Double Induction, (2) on G-CSF Priming, and (3) on High-dose Chemotherapy With Stem Cell Transplantation
Study Start Date : June 1999
Actual Primary Completion Date : January 2007
Actual Study Completion Date : October 2012

Intervention Details:
  • Drug: Cytarabine
    see protocol
  • Drug: Thioguanine
    see protocol
  • Drug: Daunorubicin
    see protocol
  • Drug: Cyclophosphamide
    see protocol
  • Drug: G-CSF
    see protocol
  • Procedure: Autologous stem cell transplantation
    for details see protocol
  • Procedure: Allogeneic stem cell transplantation
    for details see protocol

Primary Outcome Measures :
  1. Remission rate, Remission duration,Relapse-free survival, Overall survival, Event-free survival [ Time Frame: 12-18months ]

Secondary Outcome Measures :
  1. Time and dose compliance, Realisation of SCT, Toxicity according to WHO [ Time Frame: 12-18months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute myeloid leukemia (de-novo AML, secondary AML, high-risk MDS)
  • Age 16 - no upper age limit
  • Written informed consent

Exclusion Criteria:

  • Severe comorbidity
  • Presence of other malignancy
  • Prior anti-leukemic treatment
  • Pregnancy
  • Severe psychiatric disorder or other circumstances which may compromise cooperation of the patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00266136

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University of Muenster, Medical Center, Department of Medicine, Hematology and Oncology
Muenster, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
Deutsche Krebshilfe e.V., Bonn (Germany)
German Federal Ministry of Education and Research
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Study Chair: Thomas Buechner, MD PhD University of Muenster, Medical Center, Department of Medicine, Hematology and Oncology
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Prof. Dr. Thomas Büchner, Prof. Dr. Thomas Büchner MD PhD, University Hospital Muenster, University Hospital Muenster Identifier: NCT00266136    
Other Study ID Numbers: AMLCG 99
BMBF 01 GI 02070
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012
Keywords provided by Prof. Dr. Thomas Büchner, University Hospital Muenster:
AML treatment, de-novo, secondary, high-risk MDS, chemotherapy, autologous SCT, adult
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors