Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (DASAPOST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dynamic Solutions
Bristol-Myers Squibb
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT01802450
First received: February 27, 2013
Last updated: September 16, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Chronic Myeloid Leukemia
Drug: Dasatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-label, Non-randomized Phase II Trial of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CP-CML) Who Meet Criteria for Late Suboptimal Response After Prior Imatinib Treatment

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Asses the efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Asses the efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To assess the efficacy of dasatinib in terms of depth and kinetics of molecular response

  • Assess the relationship of dasatinib with the appearance of large granular lymphocytes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess the relationship of dasatinib with the appearance of large granular lymphocytes and assess the relationship of LGL with efficacy and toxicity


Enrollment: 18
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dasatinib (Sprycel)
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

Detailed Description:

This is a single-arm, open-label, phase II trial for patients in complete cytogenetic response that have not achieved major molecular response or have lost a prior major molecular response, after at least 18 months of treatment with imatinib.

All enrolled patients will receive dasatinib 100 mg once daily orally for 1 year until progression, loss of cytogenetic response, transformation to advanced phases, unacceptable toxicity (clinical adverse event, lab abnormality or concurrent disease), pregnancy if a female or withdrawal of consent, whichever happens first. Patients will undergo BCR-ABL assessments at study entry and every 3 months (central lab) and immunophenotyping and studies for clonal lymphocytosis at study entry, at 3 and 6 months.

Cytogenetic assessment will be done only if loss of response/progression/clonal evolution are suspected.

Subjects will be evaluated for the efficacy and safety of dasatinib (Sprycel). Lymphocytosis data will be collected for all patients and separate description for efficacy and safety parameters will be done in patients with and without lymphocytosis.

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802450

Locations
Spain
Hospital Txagorritxu
Vitoria, Alava, Spain, 01010
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Complejo Hospitalario de Toledo - Hospital Virgen de la Salud
Toledo, Castilla La Mancha, Spain, 45004
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain, 15706
Hospital San Pedro de La Rioja
Logroño, La Rioja, Spain, 26006
Hospital POVISA
Vigo, Pontevedra, Spain, 36211
Institut Catalá d'Oncologia L'Hospitallet
Barcelona, Spain, 08907
Hospital de León
León, Spain, 24071
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Sponsors and Collaborators
PETHEMA Foundation
Dynamic Solutions
Bristol-Myers Squibb
Investigators
Study Chair: Steegmann Juan Luis, Dr PETHEMA Foundation
Study Chair: García Valentín, Dr PETHEMA Foundation
  More Information

Additional Information:
Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT01802450     History of Changes
Other Study ID Numbers: DASAPOST 
Study First Received: February 27, 2013
Last Updated: September 16, 2015
Health Authority: Spain: Health Ministry

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Dasatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016