"AIDA" Protocol (LAP 0493)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Gruppo Italiano Malattie EMatologiche dell'Adulto

ClinicalTrials.gov Identifier:

NCT01064557

First received: February 5, 2010

Last updated: NA

Last verified: February 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 5, 2010
Last Updated Date	February 5, 2010
Start Date ^ICMJE	October 1993
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: February 5, 2010)	To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: February 5, 2010)	To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase To evaluate teh role of maintenance therapy with ATRA and chemotherapy in PCR positive patients at the end of the consolidation phase not eligible for a BMT procedure To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	"AIDA" Protocol (LAP 0493)
Official Title ^ICMJE	Treatment of Newly Diagnosed Patients Eith Acutypromyelocytic Leukemia, Aged > 12 Months (1 Year) and <75 Years, Using All-trans Retinoic Acid in Combination With Idarubicin
Brief Summary	The main purposes of the AIDA protocol are to test teh role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at teh end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Leukemia
Intervention ^ICMJE	Drug: all-trans retinoic acid (ATRA)
Study Arm (s)	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	Recruiting
Estimated Enrollment ^ICMJE	1068
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age > 12 months (1 year) and < 75 years Morphological newly diagnosis of APL Presence of the PML-RARa transcript No cardiac contraindications to anthracycline chemotherapy Serum creatinine <=2.5 mg/dL Serum alkaline phosphatase <= 3 times the normal upper limit Serum bilirubin <= 3 times the normal upper limit Serum SGOT <= 3 times the upper normal limit Negative pregnancy test Informed consent Exclusion Criteria: Age <= 12 months and >=75 years absence of the PML-RARa transcript Preganant of lactating women Presence of active serious infections that are not controlled by antibiotics Prior treatment with antileukemic therapy (excluded corticosteroids) Presence of severe concomitant psychiatric disease Presence of other concomitant malignant tumors, except basal cell carcinoma Concurrent treatment with cytotoxic chemotherapy or radiotherapy Cardiac contraindications to anthracycline chemotherapy Serum creatinine >2.5 mg/dL Serum alkaline phosphatase > 3 times the normal upper limit Serum bilirubin > 3 times the normal upper limit Serum SGOT > 3 times the upper normal limit Positive pregnancy test Absence of informed consent
Gender	Both
Ages	1 Year to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01064557
Other Study ID Numbers ^ICMJE	AIDA0493
Has Data Monitoring Committee	No
Responsible Party	Prof. Franco Mandelli, GIMEMA
Study Sponsor ^ICMJE	Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Gruppo Italiano Malattie EMatologiche dell'Adulto
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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