Back to resultsAIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
Primary Purpose
Leukemia, Promyelocytic, Acute
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
all-trans retinoid acid
idarubicin
mitoxantrone
daunorubicin
cytarabine
Sponsored by
About this trial
This is an interventional prevention trial for Leukemia, Promyelocytic, Acute focused on measuring acute promyelocytic leukemia, risk adapted therapy
Eligibility Criteria
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
Sites / Locations
- Department of Medicine I, University Hospital Carl Gustav CarusRecruiting
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
toxicity of the regimen
evaluation of additional risk factors
effectiveness of MRD as guidance for therapy decisions
relapse free survival
complete remission rate
Full Information
NCT ID
NCT00180128
First Posted
September 12, 2005
Last Updated
July 8, 2011
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT00180128
Brief Title
AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
Official Title
AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Technische Universität Dresden
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Promyelocytic, Acute
Keywords
acute promyelocytic leukemia, risk adapted therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
all-trans retinoid acid
Intervention Type
Drug
Intervention Name(s)
idarubicin
Intervention Type
Drug
Intervention Name(s)
mitoxantrone
Intervention Type
Drug
Intervention Name(s)
daunorubicin
Intervention Type
Drug
Intervention Name(s)
cytarabine
Primary Outcome Measure Information:
Title
overall survival
Secondary Outcome Measure Information:
Title
toxicity of the regimen
Title
evaluation of additional risk factors
Title
effectiveness of MRD as guidance for therapy decisions
Title
relapse free survival
Title
complete remission rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Schaich, MD
Phone
+49-351-458
Ext
-4251
Email
markus.schaich@uniklinikum-dresden.de
First Name & Middle Initial & Last Name or Official Title & Degree
Silke Soucek
Phone
+49-351-458
Ext
-4251
Email
silke.soucek@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Ehninger, MD
Organizational Affiliation
Department of Medicine I, University Hospital Carl Gustav Carus Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine I, University Hospital Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Schaich, MD
Phone
+49-351-458
Ext
-4251
Email
markus.schaich@uniklinikum-dresden.de
First Name & Middle Initial & Last Name & Degree
Silke Soucek
Phone
+49-351-458
Ext
-4251
Email
silke.soucek@uniklinikum-dresden.de
12. IPD Sharing Statement
Learn more about this trial
AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
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