Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase

NCT01802450 | Unknown Phase 2 DMC

• 1 other identifier: DASAPOST
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 15

Brief Summary

Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Asses the efficacy

  To assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600

  1 year

Secondary Outcomes (2)

• Asses the efficacy

  1 year

• Assess the relationship of dasatinib with the appearance of large granular lymphocytes

  6 months

Study Arms (1)

Dasatinib (Sprycel)

EXPERIMENTAL

Dasatinib (Sprycel): 100 mg QD administered orally as continuous daily dosing (CDD)until disease progression or adverse events that, by protocol definition or Investigator judgment, would preclude further treatment with dasatinib

Drug: Dasatinib

Interventions

Dasatinib DRUG

Dasatinib (Sprycel)

Eligibility Criteria

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

You may qualify if:

• Adult patients \>or = 18 years
• Diagnostic of Ph+ Chronic Myeloid Leukemia in first chronic phase
• Treated with Imatinib 400 mg per day or 600 mg per day for at least 18 months. A wash out period of at least 7 days for imatinib is required prior to dasatinib administration
• Patients meet criteria of late suboptimal response (complete cytogenetic response with no major molecular response) or have lost major molecular response
• Ability to understand and voluntarily sign the informed consent for
• 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 72 hours prior to study drug start.
• Sexually active men must also use effective contraceptive methods during the treatment.
• Women must not be breastfeeding

You may not qualify if:

• Patients treated with Imatinib at a dose different of 400/600 mg per day
• Patients treated with other TKI than imatinib
• Loss of cytogenetic response at study entry
• ECOG ≥ 3
• Inadequate bone marrow reserve: ANC \<1.5 x 109/L and/or Platelet count \< 100 x 109/L
• Inadequate hepatic function (Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)\> 2.5 X institutional upper limit of normal (IULN). Total bilirubin \> 1.5 X IULN (unless Gilbert syndrome has been diagnosed)
• Inadequate renal function (serum Cr \>3 UNL or ClCr \<45 ml/min)
• Patients receiving concurrent treatment with other experimental drugs or anti-cancer therapy
• Patients with uncontrolled concurrent disease:
• Known pleural effusion at baseline Clinically-significant gastrointestinal disease or surgery that would compromise absorption of study drug (eg, uncontrolled nausea or malabsorption syndrome) Clinically-significant known coagulation or platelet function disorder (not related to thrombocytopenia), eg, von Willebrand's disease Other active malignancy requiring concurrent intervention
• Uncontrolled or significant cardiovascular disease, including any of the following:
• Myocardial infarction within 6 months of enrolment date Uncontrolled angina or congestive heart failure within 3 months of enrolment date Left ventricular ejection fraction (LVEF) \< 40% Significant cardiac conduction abnormality, including history of clinically-significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), history of third degree heart block or diagnosed congenital long QT syndrome, and/or prolonged QTc/f interval \> 450 msec on baseline ECG.
• Patients with active or uncontrolled infections or with serious illnesses or medical conditions that would not permit the patient to be managed according to the protocol.
• Patients unable or unwilling to give written, informed consent prior to study participation.

Sponsors & Collaborators

• PETHEMA Foundation: lead
• Dynamic Solutions: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (15)

Hospital Txagorritxu

Vitoria-Gasteiz, Alava, 01010, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

Institut Catalá d'Oncologia L'Hospitallet

Barcelona, Barcelona, 08907, Spain

Location

Complejo Hospitalario de Toledo - Hospital Virgen de la Salud

Toledo, Castille-La Mancha, 45004, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital San Pedro de La Rioja

Logroño, La Rioja, 26006, Spain

Location

Hospital de León

León, León, 24071, Spain

Location

Hospital Universitario de la Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital POVISA

Vigo, Pontevedra, 36211, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

Related Links

• Dynamic Solutions CRO
• Bristol Myers Squibb

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Steegmann Juan Luis, Dr

  PETHEMA Foundation

  STUDY CHAIR

• García Valentín, Dr

  PETHEMA Foundation

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 1, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2016
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

ES (15)