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
| ISRCTN | ISRCTN44728648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44728648 |
| Secondary identifying numbers | DASA-TRAS |
- Submission date
- 25/10/2010
- Registration date
- 04/11/2010
- Last edited
- 04/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Guillermo Sanz
Scientific
Scientific
Hospital la Fe
Avda. Campanar, 21.
Valencia
46009
Spain
Study information
| Study design | Multicentre pilot single arm open label Phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| 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 |
| Study acronym | DASA-TRAS |
| Study objectives | 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(s) | The local ethics committee (Comité Ético Investigación Clínica [CEIC], Hospital La Fe) approved on the 19th of December 2009 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 08/04/2010 |
| Completion date | 08/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 Patients |
| Key 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 |
| Key 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. |
| Date of first enrolment | 08/04/2010 |
| Date of final enrolment | 08/04/2014 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital la Fe
Valencia
46009
Spain
46009
Spain
Sponsor information
Spanish Group of Hematopoietic Transplantation and Cell Therapy (GETH) (Spain)
Research organisation
Research organisation
C/ Fortuna, nº 51, local 5
Madrid
28010
Spain
"ROR" |
https://ror.org/015xc6321 |
|---|
Funders
Funder type
Research organisation
Spanish Group of Hematopoietic Transplantation and Cell Therapy (Grupo Español de Transplantes Hematopoyéticos y Terapia celular [GETH]) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
