CClinicalTrials.gg
Sign In
Status unknownNCT01627132Updated Jun 25, 2012

Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial

A Phase 2 interventional study of Dasatinib in Chronic Myeloid Leukemia, sponsored by Shimousa Hematology Study Group. Status unknown at 1 site in Japan. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2012-06-25.

Sponsored by Shimousa Hematology Study Group · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
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

  • Chronic Myeloid Leukemia
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 50 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

This is the only study on the registry with Shimousa Hematology Study Group as lead sponsor.

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
No

Inclusion criteria

  • Chronic Myeloid Leukemia in the Chronic Phase.
  • Patients with BCR-ABL-negative checks.
  • 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.
  • Patients with complications or a history of severe.
  • Patients with mutation of T315I、F317L、V299L.
  • Patients with additional chromosome abnormalities.
  • The case of Pleural effusion with poor control.
  • Patients with a history of hematopoietic stem cell transplantation.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    dasatinib

    Drug: Dasatinib

Interventions

  • DrugDasatinib

    100mg QD

    Also known as: BMS-354825

06

What researchers measure

Primary outcomes

  1. The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.

    Time frame: at 12 months

Secondary outcomes

  1. Rate of complete molecular remission that will be sustained after dasatinib rechallenge.

    Time frame: at 12 months

07

Study locations

1 of 1 sites recruiting
  • Nippon Medical School
    Sendagi 1-1-5, Bunkyo-ku,Tokyo 113-8603, Japan
    Recruiting
08

References and documents

Publications

  • Kumagai T, Nakaseko C, Nishiwaki K, Yoshida C, Ohashi K, Takezako N, Takano H, Kouzai Y, Murase T, Matsue K, Morita S, Sakamoto J, Wakita H, Sakamaki H, Inokuchi K; Kanto CML, Shimousa Hematology Study Groups. Silent NK/T cell reactions to dasatinib during sustained deep molecular response before cessation are associated with longer treatment-free remission. Cancer Sci. 2020 Aug;111(8):2923-2934. doi: 10.1111/cas.14518. Epub 2020 Jun 26. PubMed 32614159 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01627132
Lead sponsor
Shimousa Hematology Study Group
Collaborators
Epidemiological and Clinical Research Information Network
Responsible party
Koiti Inokuchi,MD,PhD. (Nippon Medical School, Shimousa Hematology Study Group) — Principal investigator
First posted
Jun 25, 2012
Start date
Feb 2012
Primary completion
Feb 2017 (estimated)
Completion
Jan 2019 (estimated)
Last update
Jun 25, 2012

Study contacts

Koiti Inokuchi, MD,PhD
Contact
inokuchi@nms.ac.jp
+81(0)3-3822-2131
Koiti Inokuchi
principal investigator · Nippon Medical School

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia→

Start the discussion