Chronic Myeloid LeukemiaNCT00854841
The Randomized Study of Dasatinib and High-Dose Imatinib (600mg) in Suboptimal Responder
A study testing Dasatinib and Imatinib in people with Chronic Myeloid Leukemia, run by Pusan National University Hospital.
Trial summary
Research 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Dasatinib and Imatinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Signed written informed consent, at least 18 years old
- Adequate hepatic renal function
- Dasatinib naïve patients
- Patients with cytogenetically and/or molecularly confirmed Philadelphia chromosome or BCR-ABL positive CP-CML who have been treated with standard dose of imatinib.
- ECOG status: 0-2
- 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.
Who cannot join
- Concurrent malignancy
- Patients who have received SCT
- Allergy or hypersensitivity reaction to the study drugs
- Female who are pregnant or breast feeding.
- T315I mutation
- History of significant bleeding disorder
Show all 10Show fewer
- Women of child bearing potential
- Uncontrolled or significant CVS disease: IHD. CHF
- Prior imatinib>400mg, imatinib>18 months
- Intolerance to imatinib 400mg
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized, 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)
Research 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.
Read more
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.
Read the detailed description
Study 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.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Dasatinib and Imatinib
- Keywords
- CML, suboptimal response, dasatinib, imatinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib and ImatinibDrug
Also called Sprycel and Gliveec
Dasatinib Dasatinib will be administered orally at a dose of 100 mg QD. During the first month, subjects will be instructed to take dasatinib in the morning.
Imatinib Imatinib will be administered orally at a dose of 600 mg once daily (QD). Each 600 mg dose should be administered with a meal and taken with a large glass of water. If a scheduled dose is missed for more than 12 hours or dosing is interrupted for toxicity or for any other reason, these doses should be omitted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jooseop Chung, MD. PhD, Principal investigator, Pusan National University Hospital, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854841
- Sponsor's protocol ID
- CA180-257
- Other IDs
- KCML02
- Status last verified
- Mar 2009
- First submitted
- 2 Mar 2009
- Last updated
- 3 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 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)
- ClinicalTrials.gov ID
- NCT00854841
- Acronym / sponsor ID
- CA180-257
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- CML, suboptimal response, dasatinib, imatinib
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- First posted
- 3 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research 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.
Detailed description
Study 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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent, at least 18 years old
- Adequate hepatic renal function
- Dasatinib naïve patients
- Patients with cytogenetically and/or molecularly confirmed Philadelphia chromosome or BCR-ABL positive CP-CML who have been treated with standard dose of imatinib.
- ECOG status: 0-2
Key exclusion criteria (10 listed)
- Concurrent malignancy
- Patients who have received SCT
- Allergy or hypersensitivity reaction to the study drugs
- Female who are pregnant or breast feeding.
- T315I mutation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib and ImatinibAlso: Sprycel and GliveecDasatinib Dasatinib will be administered orally at a dose of 100 mg QD. During the first month, subjects will be instructed to take dasatinib in the morning. Imatinib Imatinib will be administered orally at a dose of 600 mg once daily (QD). Each 600 mg dose should be administered with a meal and taken with a large glass of water. If a scheduled dose is missed for more than 12 hours or dosing is interrupted for toxicity or for any other reason, these doses should be omitted. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jooseop Chung, MD. PhD principal investigator
Pusan National University Hospital, Korea
Questions about this trial
What is this clinical trial studying?
A study testing Dasatinib and Imatinib in people with Chronic Myeloid Leukemia, run by Pusan National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jooseop Chung, MD. PhD (82-51-240-7242 ext. 7242, hemon@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2009.