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

K

Kanto CML Study Group

Status and phase

Unknown
Phase 2

Conditions

Myelogenous Leukemia, Chronic, Chronic Phase

Treatments

Drug: dasatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT01887561
KCSG-04

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

15+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

treatment
No Intervention group
Treatment:
Drug: dasatinib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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