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

NCT02975115 | Unknown DMC

• 1 other identifier: PCR-DEPTH
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Myelocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Rate of CMR(complete molecular response)

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

  36 month

Secondary Outcomes (1)

• Rate of MMR(major molecular response)

  3,6,12,24 and 36 months

Interventions

RQ-PCR RNA Analysis OTHER

Conventional Q-RT-PCR every 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• Bristol-Myers Squibb: collaborator

Related 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;52(5):896-904. doi: 10.3109/10428194.2011.555569. Epub 2011 Feb 21.

  PMID: 21338281 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Rest of RNA samples after Q-RT-PCR analysis

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 29, 2016
• Study Start: November 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2018
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share