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

Sponsor

Seoul St. Mary's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04150471

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

62.4

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myelocytic Leukemia	Other: RQ-PCR(Real-time Quantitative Polymerase chain reaction) RNA Analysis

Detailed Description

Patients will sign the consent forms for screening prior to frontline dasatinib therapy (1st) and the 3 month molecular test date (2nd). The molecular samples will be analyzed in the central lab as part of the screening procedure.

Subjects will be treated for a maximum of 60 months after allocation of the last subject on the assigned regimen (dasatinib 80mg QD), unless disease progression, treatment failure or unacceptable toxicity occurs, the subject withdraws consent, or the study is discontinued by the sponsor. Subjects who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to 5 years after allocation of the last subject. All subjects will be followed yearly for progression-free survival and overall survival.

For patients who continue their assigned treatment, safety assessments will be conducted every 6 months and cytogenetic assessment as investigator assessment.

Follow up visits after the last dose of study drug will be required at least every 4 weeks until all study related toxicities resolve to baseline (or CTC Grade ≤ 1), stabilize or are deemed irreversible.

Study Design

Study Type:

Observational

Anticipated Enrollment :

79 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

An Open Label, Observational Clinical Study to Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Any Grade of Adverse Events and Early Molecular Response Within 3 Months of Frontline Dasatinib Therapy

Actual Study Start Date :

Oct 18, 2018

Anticipated Primary Completion Date :

Dec 30, 2020

Anticipated Study Completion Date :

Dec 30, 2023

Outcome Measures

Primary Outcome Measures

Rate of MMR [12 month]
Level of Bcr-Abl transcript (Conventional Q-RT-PCR)

Secondary Outcome Measures

To assess: Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v4.0. [12 months]
Safety
MMR and MR4.5 rates by 5 years [5 years]
Level of Bcr-Abl transcript (Conventional Q-RT-PCR)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).
Adequate cardiac function (see exclusion criteria)
Adequate pulmonary function (see exclusion criteria)
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

Exclusion Criteria:

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
Patients who are pregnant or breast feeding or likely to become pregnant
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St. Mary's Hospital	Seoul		Korea, Republic of	137-701

Sponsors and Collaborators

Seoul St. Mary's Hospital
Bristol-Myers Squibb

Investigators

Study Director: Sahee Park, Cancer Research Institute, The Catholic University of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dong-Wook Kim, Director, Seoul St. Mary's Hospital

ClinicalTrials.gov Identifier:

NCT04150471

Other Study ID Numbers:

DAS-CHANGE

First Posted:

Nov 4, 2019

Last Update Posted:

Nov 4, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Study Results

No Results Posted as of Nov 4, 2019