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Status unknownNCT02975115Updated Nov 29, 2016

Evaluating True PCR-negative Rate of Frontline Dasatinib in Early Chronic Phase CML for Therapeutic Harmonization

An observational study in Chronic Myelocytic Leukemia, sponsored by Seoul St. Mary's Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-29.

Sponsored by Seoul St. Mary's Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Enrollment
102
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to confirm the efficacy of dasatinib 100mg once daily in producing a complete molecular response and to prove a possibility of "Operational Cure" in CMR patients.

Read the detailed description

This study also examines kinetics of complete molecular responses using new highly sensitive PCR based technology, digital PCR, which is reported to have a sensitivity down to 6 log reduction.

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Conditions studied

  • Chronic Myelocytic Leukemia
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In context

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

982 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.

This study's enrollment of 102 is below the median of 129 across 152 observational studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.

Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →

Lead sponsor

Seoul St. Mary's Hospital is the lead sponsor of 75 studies on the registry; 8 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newly diagnosed, CP-CML patients ≥ 18 years of age. Use of dasatinib for less than three weeks prior to study entry is allowed.

Adult patients with a molecularly confirmed diagnosis of BCR-ABL positive CML in new CP who have not been treated with any myeloablative or interferon alpha therapy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have Ph+ CML in CP
  • newly diagnosed chronic phase CML, except hydroxyurea, anagrelide and within 7 days imatinib treatment
  • Subjects must be enrolled in this study within approximately 3 months (90 days) after the date of first being diagnosed with CML. Subjects are allowed to have clonal chromosomal abnormalities in addition to the Philadelphia chromosome and remain eligible
  • 0-2 ECOG Performance Status (PS) Score
  • Adequate hepatic function test
  • Adequate renal function test
  • Adequate other organ functions
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
  • Subjects agree to sign informed consent

Exclusion criteria

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least 1 month (4 weeks) after the last dose of study medication.
  • WOCBP using a prohibited contraceptive method (Not applicable for this study).
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test at enrollment or prior to administration of study medication.
  • Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) after completion of study medication.
  • A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
  • Known pleural effusion at baseline.
  • Uncontrolled or significant cardiovascular disease
  • History of significant bleeding disorder unrelated to CML
  • Prior chemotherapy for peripheral stem cell mobilization. (Prior collection of un-mobilized peripheral blood stem cells is permitted).
  • Prior or concurrent malignancy
  • Evidence of digestive dysfunction that would prevent administration of study therapy by mouth
  • Uncontrolled diabetes
05

Study design

Observational model
Cohort
Enrollment
102 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherRQ-PCR RNA Analysis

    Conventional Q-RT-PCR every 3 months

06

What researchers measure

Primary outcomes

  1. Rate of CMR(complete molecular response)

    Level of Bcr-Abl transcript (Conventional Q-RT-PCR)

    Time frame: 36 month

Secondary outcomes

  1. Rate of MMR(major molecular response)

    Level of Bcr-Abl transcript (Conventional Q-RT-PCR)

    Time frame: 3,6,12,24 and 36 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Goh HG, Lin M, Fukushima T, Saglio G, Kim D, Choi SY, Kim SH, Lee J, Lee YS, Oh SM, Kim DW. Sensitive quantitation of minimal residual disease in chronic myeloid leukemia using nanofluidic digital polymerase chain reaction assay. Leuk Lymphoma. 2011 May;52(5):896-904. doi: 10.3109/10428194.2011.555569. Epub 2011 Feb 21. PubMed 21338281 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2013, a primary completion of Nov 2016 and a completion of Jan 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2016
First posted
Nov 29, 2016
Start
Nov 2013
Primary completionActual
Nov 2016
CompletionEst.
Jan 2018
Last update
Nov 29, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02975115
Lead sponsor
Seoul St. Mary's Hospital
Collaborators
Bristol-Myers Squibb
Responsible party
Dong-Wook Kim (Director, Seoul St. Mary's Hospital) — Principal investigator
First posted
Nov 29, 2016
Start date
Nov 2013
Primary completion
Nov 2016
Completion
Jan 2018 (estimated)
Last update
Nov 29, 2016

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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