Study of Dasatinib to Treat Philadelphia Positive Acute Lymphoblastic Leukemia (DASA-TRAS)
|ClinicalTrials.gov Identifier: NCT01310010|
Recruitment Status : Unknown
Verified September 2015 by Grupo Espanol de trasplantes hematopoyeticos y terapia celular.
Recruitment status was: Active, not recruiting
First Posted : March 7, 2011
Last Update Posted : September 29, 2015
Treatment with dasatinib 100 mg QD is safe and efficacious when given to patients with Ph+ ALL in the post SCT setting.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Lymphoblastic, Acute, Philadelphia-Positive||Drug: dasatinib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Non-randomized Phase II Pilot Study to Assess the Efficacy and Safety of Dasatinib After Allogeneic Stem Cell Transplantation in Patients With de Novo Philadelphia Positive (Bcr-abl +) Acute Lymphoblastic Leukemia|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2015|
Treatment with 100 mg QD of dasatinib (Sprycel®) administered orally as continuous daily dosing (CDD).
Other Name: (Sprycel®)
- The efficacy of dasatinib [ Time Frame: at 2 years ]The primary objective of this study is to assess the efficacy of dasatinib maintenance in terms of Disease Free Survival at 2 years in patients with Ph+ ALL who receive maintenance with dasatinib after allogeneic SCT.
- To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission [ Time Frame: at 2 years ]To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission, Relapse rate at 2 years, survival at 2 years, overall DFS, and Overall Survival (OS).
- To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT [ Time Frame: at 2 years ]To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310010
|Hospital La Fe|
|Valencia, Spain, 46009|
|Principal Investigator:||Guillermo Sanz, Doctor||Hospital La Fe de Valencia|