Study of Dasatinib to Treat Philadelphia Positive Acute Lymphoblastic Leukemia (DASA-TRAS)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|