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Trial record 31 of 144 for:    "Acute promyelocytic leukemia"

AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00180128
Recruitment Status : Unknown
Verified July 2011 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : July 11, 2011
Sponsor:
Information provided by:
Technische Universität Dresden

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date July 11, 2011
Study Start Date  ICMJE January 2000
Estimated Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2008)
overall survival
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • - overall survival
  • - relapse-free survival
  • - complete remission rate
Change History Complete list of historical versions of study NCT00180128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2008)
  • toxicity of the regimen
  • evaluation of additional risk factors
  • effectiveness of MRD as guidance for therapy decisions
  • relapse free survival
  • complete remission rate
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • - toxicity of the regimen
  • - feasibility of a risk-adapted therapy
  • - evaluation of additional risk factors
  • - effectiveness of MRD as guidance for therapy decisions
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
Official Title  ICMJE AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)
Brief Summary In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner. Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine. Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA is performed.
Detailed Description In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner. Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine. Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA is performed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Leukemia, Promyelocytic, Acute
Intervention  ICMJE
  • Drug: all-trans retinoid acid
  • Drug: idarubicin
  • Drug: mitoxantrone
  • Drug: daunorubicin
  • Drug: cytarabine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 12, 2005)
80
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2012
Estimated Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • acute promyelocytic leukemia confirmed by detection of t(15;17) and/or PML/RARa
  • no contraindication for chemotherapy
  • written informed consent

Exclusion Criteria:

- severe comorbidities

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00180128
Other Study ID Numbers  ICMJE MK1-192
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Gerhard Ehninger, Dresden University of Technology
Study Sponsor  ICMJE Technische Universität Dresden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerhard Ehninger, MD Department of Medicine I, University Hospital Carl Gustav Carus Dresden
PRS Account Technische Universität Dresden
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP