Condition category
Cancer
Date applied
25/10/2010
Date assigned
04/11/2010
Last edited
04/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Guillermo Sanz

ORCID ID

Contact details

Hospital la Fe
Avda. Campanar
21.
Valencia
46009
Spain

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

C/ Fortuna
nº 51
local 5
Madrid
28010
Spain

Sponsor type

Research organisation

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes