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

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ClinicalTrials.gov Identifier: NCT01382147
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Kompetenznetz Leukämien
Information provided by (Responsible Party):
Prof. Dr. Wolfgang Hiddemann, Ludwig-Maximilians - University of Munich

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : July 5, 2017


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




Primary Outcome Measures :
  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]. [ Time Frame: 8 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01382147


Locations
Show Show 32 study locations
Sponsors and Collaborators
Prof. Dr. Wolfgang Hiddemann
Kompetenznetz Leukämien
Investigators
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Principal Investigator: Wolfgang Hiddemann, Prof. Dr. Hospital of the University of Munich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Wolfgang Hiddemann, Director of the Department of Medicine III, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01382147    
Other Study ID Numbers: 2007-003103-12
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Daunorubicin
Mitoxantrone
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs