Acute lymphoblastic leukaemia (ALL)
Conditions
Interventions
Treatment with 100 mg QD of dasatinib (Sprycel?) administered orally as continuous daily dosing (CDD)
Sponsors
Spanish Group of Hematopoietic Transplantation and Cell Therapy (GETH) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival (DFS) at 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Spain
Outcome results
None listed