Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients

NCT04150471 | Unknown DMC

• 1 other identifier: DAS-CHANGE
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in patients with newly diagnosed CP CML (Chronic Phase Chronic Myeloid Leukemia) who have achieved EMR (\< 10% IS BCR-ABL) at 3 months after first line treatment with dasatinib. Subjects will be allocated to 80mg QD based on EMR (Early Molecular Response) achievement and early safety profile following a standard of care approach.

Conditions

Chronic Myelocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Rate of MMR

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

  12 month

Secondary Outcomes (2)

• To assess: Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  12 months

• MMR and MR4.5 rates by 5 years

  5 years

Interventions

RQ-PCR(Real-time Quantitative Polymerase chain reaction) RNA Analysis OTHER

Conventional Q-RT-PCR every 3 months

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult CML-CP Ph+ patients with BCR-ABL1 will start frontline dasatinib 100mg QD treatment. Dasatinib monotherapy must have been started within 3 months of CP-CML diagnosis. Patients having BCR-ABL1 transcript level \< 10% IS (International Standard) after 3 months of treatment with frontline dasatinib will reduce dasatinib dose to 80mg QD and all of patients must have any grade of adverse events at 3 months.

You may qualify if:

• Adult CML-CP Ph+ (Philadelpia) patients with BCR-ABL1 patients diagnosed within 3 months
• Adequate renal function defined as serum creatinine ≤ 3 times the institutional ULN(Upper limit of normal)
• Adequate hepatic function defined as: total bilirubin ≤ 2 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the institutional upper limit of normal (ULN).

You may not qualify if:

• Serum Na, K, Mg, and total serum Ca or ionized Ca levels must be greater than or equal to the institutional lower limit of normal. Subjects with low K, Mg levels, total serum Ca and/or ionized Ca must be replete to allow for protocol entry: Rescreening is permitted in the event of temporary biochemical abnormalities
• CML-CP Ph+ patients with CHR but with BCR-ABL level \< 10% IS after 3 months of frontline dasatinib 100 mg treatment. And currently persisting any grade adverse events to dasatinib 100 mg QD
• ECOG(Eastern Cooperative Oncology Group) performance status 0-2
• Women must not be pregnant
• Previous diagnosis of accelerated phase or blast crisis
• Documented any major ABL1 mutation
• A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive dasatinib
• Pulmonary arterial hypertension
• Congenital bleeding disorders
• Prior or concurrent malignancy, except for the following
• Subject with any anti-CML other than dasatinib
• Subjects with prior stem cell transplantation and/or high dose chemotherapy for CML
• Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes
• Subjects who were previously treated with over 100mg at second phase screening
• Subjects who are not tolerable to 80mg at second phase screening

Sponsors & Collaborators

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

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

RECRUITING

Related Publications (1)

• Cortes JE, Saglio G, Kantarjian HM, Baccarani M, Mayer J, Boque C, Shah NP, Chuah C, Casanova L, Bradley-Garelik B, Manos G, Hochhaus A. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients Trial. J Clin Oncol. 2016 Jul 10;34(20):2333-40. doi: 10.1200/JCO.2015.64.8899. Epub 2016 May 23.

  PMID: 27217448 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Rest of RNA samples after Q-RT-PCR (Quantitative Real-time Polymerase chain reaction) 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 Officials

• Sahee Park

  Cancer Research Institute, The Catholic University of Korea

  STUDY DIRECTOR

Central Study Contacts

Dong-Wook Kim

CONTACT

+82-2-2258-7030; dwkim@catholic.ac.kr

Study Design

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

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: November 4, 2019
• Study Start: October 18, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2023
• Last Updated: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)