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

November 23, 2016 updated by: Dong-Wook Kim, Seoul St. Mary's Hospital

The Catholic University of Korea Cancer Research Institute

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.

Study Overview

Status

Unknown

Conditions

Chronic Myelocytic Leukemia

Intervention / Treatment

Other: RQ-PCR RNA Analysis

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.

Study Type

Observational

Enrollment (Actual)

102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of CMR(complete molecular response) Time Frame: 36 month	Level of Bcr-Abl transcript (Conventional Q-RT-PCR)	36 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of MMR(major molecular response) Time Frame: 3,6,12,24 and 36 months	Level of Bcr-Abl transcript (Conventional Q-RT-PCR)	3,6,12,24 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Collaborators

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2016

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Estimate)