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

NCT ID: NCT02975115

Last Updated: 2016-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-01-31

Brief 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.

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.

Conditions

Chronic Myelocytic Leukemia

Study Design

• Observational Model Type: COHORT

Interventions

RQ-PCR RNA Analysis

Conventional Q-RT-PCR every 3 months

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong-Wook Kim

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 21338281 (View on PubMed)

Other Identifiers

PCR-DEPTH

Identifier Type: -

Identifier Source: org_study_id