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

Chronic Myelocytic Leukemia Clinical Trial

Official title:

The Catholic University of Korea Cancer Research Institute

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02975115
• Other study ID #: PCR-DEPTH
• Status: Active, not recruiting
• Phase: N/A
• First received: November 14, 2016
• Last updated: November 23, 2016
• Start date: November 2013
• Est. completion date: January 2018

Study information

• Verified date: November 2016
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: January 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Chronic Myelocytic Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• RQ-PCR RNA Analysis
Conventional Q-RT-PCR every 3 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	Bristol-Myers Squibb

References & Publications (1)

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;5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of CMR(complete molecular response)	Level of Bcr-Abl transcript (Conventional Q-RT-PCR)	36 month	No
Secondary	Rate of MMR(major molecular response)	Level of Bcr-Abl transcript (Conventional Q-RT-PCR)	3,6,12,24 and 36 months	No