AIDA2000 - Risk-Adapted Therapy for Patients With Acute P... | NCT00180128

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

NCT00180128

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

Jul 11, 2011Estimated

Enrollment

80Estimated

Phase

Phase 4

Conditions

Leukemia, Promyelocytic, Acute

Interventions

all-trans retinoid acid
idarubicin
mitoxantrone
daunorubicin
cytarabine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Nov 2012Estimated

Completion Date

Nov 2012Estimated

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2011

Last Update Posted Date

Jul 11, 2011Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival

Secondary Outcomes

Measure	Description	Time Frame
toxicity of the regimen
evaluation of additional risk factors
effectiveness of MRD as guidance for therapy decisions

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Markus Schaich, MD	Contact	+49-351-458	-4251	markus.schaich@uniklinikum-dresden.de
Silke Soucek	Contact	+49-351-458	-4251	silke.soucek@uniklinikum-dresden.de

Overall Officials

Name	Affiliation	Role
Gerhard Ehninger, MD	Department of Medicine I, University Hospital Carl Gustav Carus Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine I, University Hospital Carl Gustav Carus	Recruiting	Dresden		01307	Germany

Condition Browse Module

MeSH Terms

ID	Term
D015473	Leukemia, Promyelocytic, Acute

Ancestor Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015255	Idarubicin
D008942	Mitoxantrone
D003630	Daunorubicin
D003561	Cytarabine

Ancestor Terms

ID	Term
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
all-trans retinoid acid	Drug
idarubicin	Drug
mitoxantrone	Drug
daunorubicin	Drug
cytarabine	Drug