Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DASA-TRAS
Study information
Scientific title
Multicenter, non-randomised 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
Acronym
DASA-TRAS
Study hypothesis
Treatment with dasatinib 100 mg daily (QD) is safe and efficacious when given to patients with Philadelphia chromosome positive (Ph+) Acute Lymphoblastic Leukaemia (ALL) in the post Stem Cell Transplantation (SCT) setting
Ethics approval
The local ethics committee (Comité Ético Investigación Clínica [CEIC], Hospital La Fe) approved on the 19th of December 2009
Study design
Multicentre pilot single arm open label Phase II study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Acute lymphoblastic leukaemia (ALL); Philadelphia chromosome positive (Ph+/BCR-ABL+)
Intervention
Treatment with 100 mg QD of dasatinib (Sprycel) administered orally as continuous daily dosing (CDD)
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
Disease Free Survival (DFS) at 2 years
Secondary outcome measures
1. Duration of hematologic, cytogenetic and molecular remission
2. Relapse rate at 2 years
3. Survival at 2 years
4. Overall DFS
5. Overall Survival (OS)
Overall trial start date
08/04/2010
Overall trial end date
08/04/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult patients ≥ 18 years
2. Diagnostic confirmation of de novo Ph+ (BCL-ABL translocation) ALL
3. Patients in first/second complete remission (CR) (assessed by cytology, karyotyping, fluorescent in-situ hybridisation [FISH] and BCR/ABL reverse transcriptase- polymerase chain reaction [RT-PCR]) at transplantation
4. Patients with sustained hematologic and cytogenetic CR at the time of study entry
5. Any modality of allogeneic SCT
6. Patients are in day +180 (± 2 weeks) after allogeneic SCT with stable graft (patients may sign inform consent from day +166 on, but will not start study treatment until they have reached day +180 and not later than day + 194)
7. Ability to understand and voluntarily sign the informed consent form
8. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy and have a negative pregnancy test, a maximum of 48 hours prior to study drug start
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30 Patients
Participant exclusion criteria
1. Patients with Eastern Cooperative Oncology Group (ECOG) 3-4 at study entry
2. Any of the following laboratory abnormalities:
2.1. Absolute neutrophil count < 1.5 x 109/l or platelets < 75 x 109/l
2.2. Serum creatinine > 2.0 mg/dl (177 mmol/l)
2.3. Serum glutamic oxalacetic transaminase (SGOT) or serum glutamate piruvate transaminase (SGPT) > 5,0 x upper limit of normal (ULN)
2.4. Total bilirrubin > 3 mg/dl
3. Known HIV infection or any other uncontrolled infection at study entry
4. Known pleural effusion of any grade at study entry
5. Morphologic or cytogenetic or molecular relapse at study entry
6. Evidence of digestive dysfunction that could prevent administration of study therapy
7. Prior therapy with dasatinib
8. Other concurrent malignancy at study entry
9. Uncontrolled or significant cardiovascular disease, including myocardial infarction within 6 months, uncontrolled angina within 3 months, prolonged QT interval, congestive heart failure within 3 months and clinically significant ventricular arrhythmias
10. Any psychiatric condition that could prevent patient from signing the informed consent or could put the patient at an unacceptable risk in case of participating in the trial
11. Subjects enrolled in another clinical trial at study entry. If patients have received other investigational agent, a minimum of 30 days wash-out period must have elapsed.
Recruitment start date
08/04/2010
Recruitment end date
08/04/2014
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital la Fe
Valencia
46009
Spain
Funders
Funder type
Research organisation
Funder name
Spanish Group of Hematopoietic Transplantation and Cell Therapy (Grupo Español de Transplantes Hematopoyéticos y Terapia celular [GETH]) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list