Study of Dasatinib to Treat Philadelphia Positive Acute Lymphoblastic Leukemia

NCT01310010 | Completed Phase 2

• 1 other identifier: DASA-TRAS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Outcome Measures

Primary Outcomes (1)

• The efficacy of dasatinib

  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.

  at 2 years

Secondary Outcomes (2)

• To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission

  at 2 years

• To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT

  at 2 years

Study Arms (1)

Dasatinib

EXPERIMENTAL

Drug: dasatinib

Interventions

dasatinib DRUG

Treatment with 100 mg QD of dasatinib (Sprycel®) administered orally as continuous daily dosing (CDD).

Also known as: (Sprycel®)

Dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ≥ 18 years
• Diagnostic confirmation of de novo Ph+ ALL
• Patients in first/second CR (assessed by cytology, karyotyping and/or FISH) at transplantation
• Patients with sustained hematologic and cytogenetic CR at the time of study entry
• Any modality of allogeneic SCT
• Patients are in days between 120 until 180 after allogeneic SCT with stable graft.
• Ability to understand and voluntarily sign the informed consent form
• 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

You may not qualify if:

• Patients with ECOG 3-4 at study entry
• 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.
• Known HIV infection or any other uncontrolled infection at study entry
• Known pleural effusion of any grade at study entry.
• Morphologic or cytogenetic or molecular relapse at study entry
• Evidence of digestive dysfunction that could prevent administration of study therapy
• Prior therapy with dasatinib during \>21 days
• Other concurrent malignancy at study entry
• 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
• 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
• 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.

Sponsors & Collaborators

• Grupo Espanol de trasplantes hematopoyeticos y terapia celular: lead

Study Sites (1)

Hospital La Fe

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Guillermo Sanz, Doctor

  Hospital La Fe de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: March 7, 2011
• Study Start: April 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: July 1, 2016
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

ES (1)