Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib

NCT ID: NCT01593254

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-12
• Study Completion Date: 2022-04-12

Brief Summary

The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

Conditions

Chronic Phase Chronic Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Imatinib (≥400 mg)

Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months

Group Type: ACTIVE_COMPARATOR

Imatinib

Intervention Type: DRUG

Arm 2: Dasatinib (100 mg)

Dasatinib 100 mg tablet by mouth QD up to 60 months

Group Type: ACTIVE_COMPARATOR

Dasatinib

Intervention Type: DRUG

Interventions

Imatinib

Intervention Type: DRUG

Dasatinib

Intervention Type: DRUG

Other Intervention Names

Gleevec; Glivec; Sprycel

Eligibility Criteria

Inclusion Criteria

• Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (CHR) but without one log BCR-ABL reduction (BCR-ABL level >10% IS) 3 months of imatinib 400mg treatment. (Imatinib transient dose adjustments due to Adverse Event (AEs) are allowed with a maximum of 2 weeks interruption of treatment with imatinib (cumulative) within the 3 month period before randomization). Imatinib monotherapy must have been started within 6 months of CP-CML diagnosis (Ph + /BCR-ABL detection)
• Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment interruption or dose reductions are required to be on treatment with 400 mg imatinib for two weeks immediately prior to randomization to ensure tolerance to imatinib
• Eastern Co-Operative Group (ECOG) performance status = 0 - 2
• Adequate renal function defined as serum creatinine ≤3 times the institutional upper limit of normal (ULN)
• Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the institutional ULN

Exclusion Criteria

• Previous diagnosis of accelerated phase or blast crisis
• Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases at baseline bone marrow cytogenetic test, unless the same abnormalities were present at diagnosis. Patients with no evidence of clonal evolution, including those patients whose cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months, are eligible for the study
• Subjects with less than CHR after 3 months of imatinib treatment or lost CHR after initial achievement
• Documented T315I/A, F317L, or V299L mutations (if already available - not required for screening)
• A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy

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

Sponsors

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

Molecular MD

UNKNOWN

Sponsor Role: collaborator

MultiPharma

UNKNOWN

Sponsor Role: collaborator

Q2 Solutions

INDUSTRY

Sponsor Role: collaborator

Donald E. Morisky

UNKNOWN

Sponsor Role: collaborator

MD Anderson Symptom Inventory (MDASI-CML)

UNKNOWN

Sponsor Role: collaborator

OBiS, Inc

UNKNOWN

Sponsor Role: collaborator

Steering Committee

UNKNOWN

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 0004

Anaheim, California, United States

Local Institution - 0006

Fontana, California, United States

University Of Southern California University Hospital

Los Angeles, California, United States

Local Institution - 0110

Roseville, California, United States

Local Institution - 0112

San Jose, California, United States

Local Institution - 0009

Vallejo, California, United States

Local Institution - 0078

Whittier, California, United States

Local Institution - 0089

Southington, Connecticut, United States

Northwestern University

Evanston, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northern Indiana Cancer Research Consortium

Crown Point, Indiana, United States

Franciscan St. Francis Health

Indianapolis, Indiana, United States

University Of Iowa

Iowa City, Iowa, United States

Local Institution - 0010

Rochester, Minnesota, United States

Local Institution - 0002

Cincinnati, Ohio, United States

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Local Institution - 0001

Nashville, Tennessee, United States

Michael E Debakey VAMC

Houston, Texas, United States

Institute of Oncology Hematology Biomedical Research

Laredo, Texas, United States

Edwards Comprehensive Cancer Center

Huntington, West Virginia, United States

Local Institution - 0005

Milwaukee, Wisconsin, United States

Local Institution - 0093

La Plata, Buenos Aires, Argentina

Local Institution - 0080

Ramos Mejía, Buenos Aires, Argentina

Local Institution - 0049

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0051

Buenos Aires, , Argentina

Local Institution - 0057

Buenos Aires, , Argentina

Local Institution - 0100

Corrientes, , Argentina

Local Institution - 0026

Innsbruck, Tyrol, Austria

Local Institution - 0022

Wels, Upper Austria, Austria

Local Institution

Fürstenfeld, , Austria

Local Institution - 0043

Graz, , Austria

Local Institution - 0024

Linz, , Austria

Local Institution - 0023

Vienna, , Austria

Local Institution - 0065

Bruges, , Belgium

Local Institution - 0099

Merksem, , Belgium

Local Institution

Yvoir, , Belgium

Local Institution - 0083

Goiânia, Goiás, Brazil

Local Institution

Curitiba, Paraná, Brazil

Local Institution - 0063

Campinas, São Paulo, Brazil

Local Institution

Ribeirão Preto, São Paulo, Brazil

Local Institution - 0059

São Paulo, São Paulo, Brazil

Local Institution - 0062

Rio de Janeiro, , Brazil

Local Institution - 0058

Rio de Janeiro, , Brazil

Local Institution - 0111

Rio de Janeiro, , Brazil

Local Institution - 0020

Saint John, New Brunswick, Canada

Local Institution - 0071

Beijing, Beijing Municipality, China

Local Institution - 0086

Beijing, Beijing Municipality, China

Local Institution - 0070

Fuzhou, Fujian, China

Local Institution - 0103

Shenzhen, Guandong, China

Local Institution - 0082

Guangzhou, Guangdong, China

Local Institution - 0074

Guangzhou, Guangdong, China

Local Institution - 0084

Haerbin, Heilongjiang, China

Local Institution - 0102

Wuhan, Hubei, China

Local Institution - 0073

Nanjing, Jiangsu, China

Local Institution - 0077

Suzhou, Jiangsu, China

Local Institution - 0094

Shenyang, Liaoning, China

Local Institution - 0088

Xi'an, Shan3xi, China

Local Institution - 0101

Jinan, Shandong, China

Local Institution - 0075

Chengdu, Sichuan, China

Local Institution - 0069

Tianjin, Tianjin Municipality, China

Local Institution - 0072

Hangzhou, , China

Local Institution - 0076

Shanghai, , China

Local Institution - 0096

Wuhan, , China

Local Institution - 0032

Brno, Czech Republic, Czechia

Local Institution

Hradec Králové, , Czechia

Local Institution

Olomouc, , Czechia

Local Institution

Prague, , Czechia

Local Institution - 0067

Prague, , Czechia

Local Institution - 0045

Le Chesnay, , France

Local Institution - 0041

Lille, , France

Local Institution

Nantes, , France

Local Institution

Pierre-Bénite, , France

Local Institution - 0038

Vandœuvre-lès-Nancy, , France

Local Institution

Budapest, , Hungary

Local Institution - 0104

Szeged, , Hungary

Local Institution - 0106

Brescia, Province Of Brescia, Italy

Local Institution

Bari, , Italy

Local Institution

Bologna, , Italy

Local Institution

Catania, , Italy

Local Institution - 0027

Florence, , Italy

Local Institution - 0046

Monza, , Italy

Local Institution

Napoli, , Italy

Local Institution - 0025

Orbassano, , Italy

Local Institution - 0021

Roma, , Italy

Local Institution - 0033

Rome, , Italy

Local Institution - 0048

Krakow, Lesser Poland Voivodeship, Poland

Local Institution - 0047

Gdansk, , Poland

Local Institution - 0098

Katowice, , Poland

Local Institution - 0064

Warsaw, , Poland

Local Institution - 0039

Seoul, , South Korea

Local Institution - 0050

Seoul, , South Korea

Local Institution - 0040

Seoul, , South Korea

Local Institution - 0017

A Couruna, , Spain

Local Institution - 0018

L'Hospitalet Del Llobregat, , Spain

Local Institution - 0015

Las Palmas de Gran Canaria, , Spain

Local Institution - 0012

Madrid, , Spain

Local Institution - 0013

Salamanca, , Spain

Local Institution - 0011

Toledo, , Spain

Local Institution - 0055

Muang, Chiang Mai, Thailand

Local Institution

Bangkok, , Thailand

Local Institution - 0052

Khon Kaen, , Thailand

Countries

United States; Argentina; Austria; Belgium; Brazil; Canada; China; Czechia; France; Hungary; Italy; Poland; South Korea; Spain; Thailand

References

Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Gurnani R, Saglio G. Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study. Leukemia. 2020 Aug;34(8):2064-2073. doi: 10.1038/s41375-020-0805-1. Epub 2020 Apr 7.

Reference Type: DERIVED

PMID: 32265500 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.BMSStudyConnect.com

BMS Clinical Trial Patient Recruiting

http://www.fda.gov/safety/medwatch/safetyinformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2011-006181-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA180-399

Identifier Type: -

Identifier Source: org_study_id