Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial

PhaseⅡClinical Trial of Dasatinib for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase and Stop Therapy After Achieving Complete Molecular Response for Cure D-NewS

The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission(CMR) while on dasatinib.

Study Overview

• Status: Unknown
• Conditions: Myelogenous Leukemia, Chronic, Chronic Phase
• Intervention / Treatment: Drug: dasatinib

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Tachikawa city, Tokyo, Japan, 190-0014
      • Recruiting
      • National Disaster Medical Center
      • Contact: Naoki Takesako; Phone Number: +81(0) 42-526-5511; Email: ntakezak@tdmc.hosp.go.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
• 15 years old over.
• ECOG performance status (PS) score 0-2.
• Adequate organ function (hepatic, renal and lung).
• Signed written informed consent.

Exclusion Criteria:

• A case with the double cancer of the activity.
• Women who are pregnant or breastfeeding.
• female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period
• Patients with complications or a history of severe or uncontrolled cardiovascular failure following have a Myocardial infarction within 6 months have an Angina within 3 months have a Congestive heart failure within 3 months have a QTc interval of more than 450msec at baseline
• A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: treatment	Drug: dasatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR	by 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
'Dasatinib affects immunological responses, as measured by flow cytometry	at 3,6,12,24 months
Major Molecular Response(MMR) rate measured by RQ-PCR	by 1 months, then every 6 months for 2 years
Complete Cytogenetic Response (CCyR) rate	by 6,12 months
Progression free survival (PFS)	Participants were followed for at least 2 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Participants were followed for at least 2 years
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR	by 3,6 months
Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse	by 12 months after molecular relapse
Complete Molecular Response(CMR) rate measured by RQ-PCR	by 1 months, then every 6 months for 2 years

Collaborators and Investigators

• Sponsor: Kanto CML Study Group

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 11, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (Estimate): June 27, 2013

Study Record Updates

• Last Update Posted (Estimate): June 27, 2013
• Last Update Submitted That Met QC Criteria: June 24, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Dasatinib
• Other Study ID Numbers: KCSG-04