AML Treatment in Untreated Adult Patients (LAM99P)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00449319|
Recruitment Status : Recruiting
First Posted : March 20, 2007
Last Update Posted : November 17, 2017
The present therapy intends to be an homogeneous treatment for AML patients based on a pretreatment with hydroxiurea plus an induction therapy with the standard arm with Daunorubicine as according to EORTC-GIMEMA AML10 study.
The post-remissional treatment is based on transplant with HLA compatible donor is foreseen for all patients and autologous transplant for those without HLA compatible donor available.
|Condition or disease||Intervention/treatment|
|Leukemia, Myelocytic, Acute||Procedure: Identification of appropriate therapies according to risks factors Drug: Daunorubicine Procedure: Transplant|
GIMEMA treatment for adult (15-60 yrs) AML patients included a 3-drug induction cycle with DNR (50 mg/m2 d 1, 3, 5), cytarabine (100 mg/m2 d1-10), etoposide (100 mg/m2 d1-5) followed by an intensive consolidation with cytarabine (500 mg/m2/q12 hrs d1-d6) and the same anthracycline as in induction on d 4-6. Following consolidation, eligible pts (age <45 or 55 yrs) with a HLA compatible sibling had to be allografted, the others, had to be autografted with autologous peripheral stem cell (PSC) collected during recovery from consolidation.
BM and PB samples at diagnosis were centralized according to a national GIMEMA original study planned with the aim to accurately evaluate biological characteristics at diagnosis and to identify genetic alterations with prognostic relevance and to follow up cases monitoring minimal disease during remission. To allow the adequate collection and sending of samples before starting intensive chemotherapy, all patients received a 5-day pretreatment consisting of hydroxiurea (HU) at the dosage of 2 g/m2/day, also effective for "debulkying" of disease.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10|
|Actual Study Start Date :||November 1998|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||July 2018|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449319
|Contact: Marco VIGNETTI, Dr||+39 06 firstname.lastname@example.org|
|Contact: Paola FAZI, Dr.||+39 06 email@example.com|
|Dr. De Blasio||Recruiting|
|Nocera Inferiore, Italy|
|Reggio Calabria, Italy|
|Pr. Lo Coco||Recruiting|
|San Giovanni Rotondo, Italy|
|Principal Investigator:||Franco MANDELLI, Pr.||Gruppo Italiano Malattie EMatologiche dell'Adulto|