Chronic Lymphocytic LeukemiaPhase 1NCT00872976
Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia
A Phase 1 study testing Dasatinib and Combination of Bendamustine + Dasatinib in people with Chronic Lymphocytic Leukemia, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The purpose of this study is to determine the recommended dose for the combination of dasatinib and bendamustine in chronic lymphocytic leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Dasatinib and Combination of Bendamustine + Dasatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2009to Dec 2011
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of B-CLL by NCI criteria
- Require chemotherapy and have fully recovered from previous administered chemotherapy
- Subjects must have progressed, failed to achieve a meaningful response, or relapsed/intolerant to prior therapy. Failing at least one purine analogue regimen
- Subjects have received three or fewer prior treatment regimens
- ECOG status of 0 - 2
- If dose level + 3 is reached, the criteria is the same as outlined for Cohort #1, however the subjects should not have a history of prior chemotherapy (treatment naive)
Who cannot join
- Unwilling or unable to use an acceptable method to avoid pregnancy
- Uncontrolled or significant cardiovascular disease, including prolonged QTc interval
- History of significant bleeding disorder, unrelated to CLL
- Prior concurrent malignancy
- Drugs that generally accepted to have the risk of causing Torsades de Pointes
- Autoimmune hemolytic anemia requiring therapy or transfusion support
Show all 9Show fewer
- Autoimmune thrombocytopenia requiring steroid therapy or transfusion support
- Richter's Syndrome
- Transformation to prolymphocytic leukemia
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Local Institution
Columbus, Ohio, 43210
Local Institution
Nashville, Tennessee, 37203
Local Institution
New Hyde Park, New York, 11040
About this study
Official title: Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia
The purpose of this study is to determine the recommended dose for the combination of dasatinib and bendamustine in chronic lymphocytic leukemia (CLL).
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Dasatinib, Combination of Bendamustine + Dasatinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called BMS-354825, Sprycel
One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)
Combination of Bendamustine + DasatinibDrug
Also called Sprycel, Treanda
Dasatinib, Tablets/Oral Solution, Oral, 50 mg, then at 80 mg, at 80 mg, and at 100 mg, once daily (QD), at assigned ascending dose, for 28 day cycles for a maximum of six cycles
Bendamustine, injection, IV injection, 50 mg/m²/Day 1 and Day 2, then at 50 mg/m², at 70 mg/m², at 70 mg/m², at assigned ascending dose, once daily 30 minute IV infusion Day 1 and Day 2 for a maximum of six cycles
DasatinibDrug
Also called BMS-354825, Sprycel
One Week Initial Treatment for Cohort #2: Dasatinib - Tablets/Oral Solution, at 100 mg, once daily (QD)
Combination of Bendamustine + DasatinibDrug
Also called Treanda, Sprycel
Dasatinib, Tablets/Oral Solution, Oral, at 100 mg, once daily (QD), for 28 day cycles for maximum of six cycles
Bendamustine, injection, IV injection, 100 mg/m²/Day 1 and Day 2, once daily 30 minute IV infusion Day 1 and Day 2 for maximum of six cycles
| Study group | Role | What they receive |
|---|---|---|
| Cohort #1 | Experimental | Not described Receives: Drug: Dasatinib; Drug: Combination of Bendamustine + Dasatinib |
| Cohort #2 | Experimental | Not described Receives: Drug: Dasatinib; Drug: Combination of Bendamustine + Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level
Measured: From initial dose to the end of three cycles of treatment at each dosing level. Each cycle is 28 days, so approximately 91 days
Secondary outcomes (2)
All response evaluable subjects Cohorts #1 and #2 are assessed for overall response rate(s): complete remission (CR); CR with incomplete marrow recovery (CRi); partial remission (PR); for progressive disease (PD) or stable disease (SD)
Measured: From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days
The effects of treatment on various biological correlates will also be assayed
Measured: From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: Business Objectives Changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872976
- Sponsor's protocol ID
- CA180-182
- Status last verified
- Jul 2013
- First submitted
- 31 Mar 2009
- Last updated
- 22 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00872976
- Acronym / sponsor ID
- CA180-182
- Conditions
- Chronic Lymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Objectives Changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 1 Apr 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.
The purpose of this study is to determine the recommended dose for the combination of dasatinib and bendamustine in chronic lymphocytic leukemia (CLL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort #1 | Experimental | Drug: Dasatinib, Drug: Combination of Bendamustine + Dasatinib |
| Cohort #2 | Experimental | Drug: Dasatinib, Drug: Combination of Bendamustine + Dasatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of B-CLL by NCI criteria
- Require chemotherapy and have fully recovered from previous administered chemotherapy
- Subjects must have progressed, failed to achieve a meaningful response, or relapsed/intolerant to prior therapy. Failing at least one purine analogue regimen
- Subjects have received three or fewer prior treatment regimens
- ECOG status of 0 - 2
Key exclusion criteria (9 listed)
- Unwilling or unable to use an acceptable method to avoid pregnancy
- Uncontrolled or significant cardiovascular disease, including prolonged QTc interval
- History of significant bleeding disorder, unrelated to CLL
- Prior concurrent malignancy
- Drugs that generally accepted to have the risk of causing Torsades de Pointes
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 |
|---|---|---|
| DasatinibAlso: BMS-354825, SprycelOne Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD) | Drug | Cohort #1 |
| Combination of Bendamustine + DasatinibAlso: Sprycel, TreandaDasatinib, Tablets/Oral Solution, Oral, 50 mg, then at 80 mg, at 80 mg, and at 100 mg, once daily (QD), at assigned ascending dose, for 28 day cycles for a maximum of six cycles Bendamustine, injection, IV injection, 50 mg/m²/Day 1 and Day 2, then at 50 mg/m², at 70 mg/m², at 70 mg/m², at assigned ascending dose, once daily 30 minute IV infusion Day 1 and Day 2 for a maximum of six cycles | Drug | Cohort #1 |
| DasatinibAlso: BMS-354825, SprycelOne Week Initial Treatment for Cohort #2: Dasatinib - Tablets/Oral Solution, at 100 mg, once daily (QD) | Drug | Cohort #2 |
| Combination of Bendamustine + DasatinibAlso: Treanda, SprycelDasatinib, Tablets/Oral Solution, Oral, at 100 mg, once daily (QD), for 28 day cycles for maximum of six cycles Bendamustine, injection, IV injection, 100 mg/m²/Day 1 and Day 2, once daily 30 minute IV infusion Day 1 and Day 2 for maximum of six cycles | Drug | Cohort #2 |
Primary outcome
Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level
Time frame: From initial dose to the end of three cycles of treatment at each dosing level. Each cycle is 28 days, so approximately 91 days
2 secondary outcomes
All response evaluable subjects Cohorts #1 and #2 are assessed for overall response rate(s): complete remission (CR); CR with incomplete marrow recovery (CRi); partial remission (PR); for progressive disease (PD) or stable disease (SD)
Time frame: From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days
The effects of treatment on various biological correlates will also be assayed
Time frame: From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dasatinib and Combination of Bendamustine + Dasatinib in people with Chronic Lymphocytic Leukemia, run by Bristol-Myers Squibb at 3 sites in United States.
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 9 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: withdrawn, as of the sponsor's last update on 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level (time frame: From initial dose to the end of three cycles of treatment at each dosing level. Each cycle is 28 days, so approximately 91 days). It is what the study was designed to measure, not a finding.
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 22 Jul 2013.