Welcome
Support Centre
22 October 2014 
Current Controlled Trials - Clinical Trials
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Introduction
English introduction Introduction en franšais Deutsche einleitung
Introducciˇn espa˝ola Introduzione in italiano
 
Find trials
active registers
mental health register
archived registers
all registers
tips on searching
 
 
Information
about mRCT
mRCT FAQs

DISCLAIMER
The site should not be used to diagnose or treat a health problem. Please consult your doctor.
Terms & conditions

DUPLICATION
Your search result may contain a number of different records for the same trial. This occurs when the same trial is listed in more than one register.

[ Print-friendly version ]
The Randomized Study of Dasatinib and High-Dose Imatinib (600mg) in Suboptimal Responder
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleThe Randomized Study of Dasatinib and High-Dose Imatinib (600mg) in Suboptimal Responder
Current status of trialAvailable
Sponsors and collaboratorsPusan National University Hospital
Information provided byPusan National University Hospital
ClinicalTrials.gov identifierNCT00854841
PurposeResearch Hypothesis:

Treatment with dasatinib 100 mg QD is superior to imatinib 600 mg QD in terms of complete
cytogenetic response (CCyR) in chronic phase (CP) Philadelphia chromosome-positive (Ph+)
Chronic Myeloid Leukemia (CML) subjects who are imatinib failures or who have achieved only
a suboptimal response after 3-18 months (12-77 weeks) of therapy with imatinib 400 mg.

Primary Objective:

The primary objective of this study is to compare the rate of CCyR of dasatinib (100mg QD)
to high-dose imatinib (600 mg QD) therapy at 6 months after randomization in CP Ph+ CML
subjects who are imatinib failures or who have achieved only a suboptimal response after 3 -
18 months of imatinib monotherapy at 400 mg/day.
Condition(s)Chronic Myeloid Leukemia
Intervention(s)Drug: Dasatinib and Imatinib
PhaseN/A
Study type and designN/A
Official titleRandomized, Open Label Study of Dasatinib (100mg qd) vs. High-Dose Imatinib (600mg) in Patients With Chronic Phase CML Who Have Had Suboptimal Response After 3-18 Months of Therapy With Imatinib (400mg)
Further study detailsStudy Design: Prospective open-label, randomized two arms, multicenter study for the
patients with suboptimal response to standard Tx to evaluate efficacy & safety of dasatinib
(100mg qd) & imatinib (600mg daily) by CyR & MoR at 3, 6 & 12 months.

- Randomized 1:1

- Crossover to alternate be permitted after confirmed PD at 3M (AP, BC & loss of CHR or
MCyR) & absence of any response at 6M.

Duration of Study: Subjects will be treated for up to 12 months, unless disease progression
or unacceptable toxicity occurs, the subject withdraws, or the study is discontinued.

Duration of Study: Subjects will be treated for up to 12 months, unless disease progression
or unacceptable toxicity occurs, the subject withdraws, or the study is discontinued.

Number of Subjects: A total of 90 subjects will be randomized in 1:1 randomization ratio

Study Population: Subjects 18 years of age or older with CP Ph+ CML and who are imatinib
failures or ave achieved only a suboptimal response after 3 - 18 months (12 - 77 weeks) of
treatment with 400 mg/day of imatinib monotherapy.

Test Product, Dose and Mode of Administration, Duration of Treatment:

Subjects in the dasatinib arm will begin treatment with dasatinib at an oral dose of 100 mg
QD. One dose reduction to 70 mg due to toxicity will be allowed. One dose escalation to 140
mg is allowed under specified circumstances.

Reference Therapy, Dose and Mode of Administration, Duration of Treatment:

Subjects in the imatinib arm will begin treatment with imatinib at an oral dose of 600 mg QD
Doses of imatinib can be escalated to 800 mg for patients with inadequate response at 3
months and dose reduction of imatinib is not permitted for any cases of patients.

Criteria for Evaluation:

Efficacy:

- Primary Endpoint: CCyR rate at 6 months after randomization.

- Secondary Endpoints:

- MMR rates at 3, 6, and 12 months

- CCyR rates at 3, 6 and 12 months

- CHR rates at 3, 6and 12 months

- Time to-, and duration of-, MMR and CCyR

- Progression free survival (PFS)

Safety:

Adverse experiences associated with dasatinib or imatinib treatment will be reported for all
treated subjects. Adverse events will be assessed continuously and graded according to the
NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Minimum age18 Years
Maximum ageN/A
GenderBoth
Eligibility criteriaInclusion Criteria:

1. Signed written informed consent, at least 18 years old

2. Adequate hepatic renal function

3. Dasatinib naïve patients

4. Patients with cytogenetically and/or molecularly confirmed Philadelphia chromosome or
BCR-ABL positive CP-CML who have been treated with standard dose of imatinib.

5. ECOG status: 0-2

6. And one of following criteria for imatinib suboptimal response 1)CP-CML patients who
have failed to achieve a CHR at 3 months or MCyR at 6 months of therapy with imatinib
400mg daily. 2)CP-CML patients who have failed to achieve a CCyR at 12 months with
imatinib 400mg daily 3)CP-CML patients who have failed to achieve a MMoR (less than 3
log reduction) at 18 months with imatinib 400mg daily 4)CP-CML patients who have lost
molecular response by an increase of BCR-ABL more than 10 times regardless treatment
duration.

Exclusion Criteria:

1. Concurrent malignancy

2. Patients who have received SCT

3. Allergy or hypersensitivity reaction to the study drugs

4. Female who are pregnant or breast feeding.

5. T315I mutation

6. History of significant bleeding disorder

7. Women of child bearing potential

8. Uncontrolled or significant CVS disease: IHD. CHF

9. Prior imatinib>400mg, imatinib>18 months

10. Intolerance to imatinib 400mg
Overall contactJooseop Chung, MD. PhD
tel: 82-51-240-7242 ext.: 7242
hemon@pusan.ac.kr
Study chairs or principal investigatorsJooseop Chung, MD. PhD, Principal Investigator, Pusan National University Hospital, Korea
Backup contactYoungjin Choi, MD. PhD
tel: 82-51-240-7201 ext.: 7212
porori701@hanmail.net
Study ID numbersCA180-257; KCML02
Last updatedMarch 2, 2009
Record first receivedMarch 2, 2009
ClinicalTrials.gov identifierNCT00854841
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 Current Controlled Trials Ltd. Part of Springer Science+Business Media. | terms & conditions | privacy statement | cookies