A 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

Completed

Conditions: Acute lymphoblastic leukaemia (ALL)
Lymphoid leukaemia
Philadelphia chromosome positive (Ph+/BCR-ABL+)
Cancer

Registration Number: ISRCTN44728648

Lead Sponsor: Spanish Group of Hematopoietic Transplantation and Cell Therapy (GETH) (Spain)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS) at 2 years

Secondary Outcome Measures

Name	Time	Method
1. Duration of hematologic, cytogenetic and molecular remission<br>2. Relapse rate at 2 years<br>3. Survival at 2 years<br>4. Overall DFS<br>5. Overall Survival (OS)