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

NCT01887561 | Unknown Phase 2 DMC

• 1 other identifier: KCSG-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myelogenous Leukemia, Chronic, Chronic Phase

Outcome Measures

Primary Outcomes (1)

• The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR

  by 12 months

Secondary Outcomes (8)

• '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

Study Arms (1)

treatment

NO INTERVENTION

Drug: dasatinib

Interventions

dasatinib DRUG

treatment

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanto CML Study Group: lead

Study Sites (1)

National Disaster Medical Center

Tachikawa, Tokyo, 190-0014, Japan

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kanto CML Study Group

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: June 27, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2012
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

JP (1)