Study of Dasatinib to Treat Philadelphia Positive Acute Lymphoblastic Leukemia (DASA-TRAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Grupo Espanol de trasplantes hematopoyeticos y terapia celular.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
ClinicalTrials.gov Identifier:
NCT01310010
First received: February 10, 2011
Last updated: September 24, 2013
Last verified: September 2011
  Purpose

Study hypothesis:

Treatment with dasatinib 100 mg QD is safe and efficacious when given to patients with Ph+ ALL in the post SCT setting.


Condition Intervention Phase
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Drug: dasatinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Non-randomized 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

Resource links provided by NLM:


Further study details as provided by Grupo Espanol de trasplantes hematopoyeticos y terapia celular:

Primary Outcome Measures:
  • The efficacy of dasatinib [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
    The primary objective of this study is to assess the efficacy of dasatinib maintenance in terms of Disease Free Survival at 2 years in patients with Ph+ ALL who receive maintenance with dasatinib after allogeneic SCT.


Secondary Outcome Measures:
  • To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
    To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission, Relapse rate at 2 years, survival at 2 years, overall DFS, and Overall Survival (OS).

  • To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT


Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dasatinib Drug: dasatinib
Treatment with 100 mg QD of dasatinib (Sprycel®) administered orally as continuous daily dosing (CDD).
Other Name: (Sprycel®)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients ≥ 18 years
  2. Diagnostic confirmation of de novo Ph+ ALL
  3. Patients in first/second CR (assessed by cytology, karyotyping and/or FISH) 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 days between 120 until 180 after allogeneic SCT with stable graft.
  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 ECOG 3-4 at study entry
  2. Any of the following laboratory abnormalities:

    • Absolute neutrophil count < 1.5 x 109/l or platelets < 75 x 109/l
    • Serum creatinine > 2.0 mg/dl (177 mmol/l).
    • Serum glutamic oxalacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 5,0 x upper limit of normal (ULN).
    • Total bilirubin > 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 during >21 days
  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 o 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310010

Locations
Spain
Hospital La Fe Recruiting
Valencia, Spain, 46009
Contact: Guillermo Sanz, Doctor    0034962410700    sanz_gvi@gva.es   
Principal Investigator: Guillermo Sanz, Doctor         
Sponsors and Collaborators
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Investigators
Principal Investigator: Guillermo Sanz, Doctor Hospital la Fe de Valencia
  More Information

No publications provided

Responsible Party: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
ClinicalTrials.gov Identifier: NCT01310010     History of Changes
Other Study ID Numbers: DASA-TRAS
Study First Received: February 10, 2011
Last Updated: September 24, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014