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Status unknownNCT01887561Updated Jun 27, 2013

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

A Phase 2 interventional study of dasatinib in Myelogenous Leukemia, Chronic, Chronic Phase, sponsored by Kanto CML Study Group. Status unknown at 1 site in Japan. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-27.

Sponsored by Kanto CML Study Group · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
15 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myelogenous Leukemia, Chronic, Chronic Phase
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 100 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Kanto CML Study Group is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • No intervention
    treatment

    Drug: dasatinib

Interventions

  • Drugdasatinib
06

What researchers measure

Primary outcomes

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

    Time frame: by 12 months

Secondary outcomes

  1. 'Dasatinib affects immunological responses, as measured by flow cytometry

    Time frame: at 3,6,12,24 months

  2. Major Molecular Response(MMR) rate measured by RQ-PCR

    Time frame: by 1 months, then every 6 months for 2 years

  3. Complete Cytogenetic Response (CCyR) rate

    Time frame: by 6,12 months

  4. Progression free survival (PFS)

    Time frame: Participants were followed for at least 2 years

  5. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Participants were followed for at least 2 years

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

    Time frame: by 3,6 months

  7. Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse

    Time frame: by 12 months after molecular relapse

  8. Complete Molecular Response(CMR) rate measured by RQ-PCR

    Time frame: by 1 months, then every 6 months for 2 years

07

Study locations

1 of 1 sites recruiting
  • National Disaster Medical Center
    Tachikawa city, Tokyo 190-0014, Japan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01887561
Lead sponsor
Kanto CML Study Group
Responsible party
Naoki Takezako, M.D., Ph.D. (Kanto CML Study Group, Kanto CML Study Group) — Principal investigator
First posted
Jun 27, 2013
Start date
Nov 2012
Primary completion
Dec 2012
Last update
Jun 27, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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