Lymphoblastic Leukemia, Acute T-cellPhase 1NCT01363817
Study to Evaluate the Safety and Tolerability of Weekly Intravenous (IV) Doses of BMS-906024 in Subjects With Acute T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
A Phase 1 study testing BMS-906024 and Dexamethasone in people with Lymphoblastic Leukemia, Acute T-cell and Precursor T-Cell Lymphoblastic Lymphoma, run by Bristol-Myers Squibb at 6 sites in 3 countries.
Trial summary
The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoblastic Leukemia, Acute T-cell, Precursor T-Cell Lymphoblastic Lymphoma
- What is being tested?
- BMS-906024 and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 28 Sep 2011to 7 Feb 2018
- 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
- Subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma refractory to or relapsed from standard therapies
- Life expectancy of at least 2 months
- Performance status (PS) 0-1 (a measure of the ability to carry out activities of daily living); subjects with PS 2 are eligible if due to disease related symptoms
- Prior anti-cancer treatment permitted (with specific criteria)
- Adequate organ function
Who cannot join
- Infection
- Elevated triglycerides
- Gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
- Unable to tolerate bone marrow biopsy
- Taking medications known to increase risk of Torsades De Pointes (an abnormal heart rhythm)
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
The University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies
Read the detailed description
Minimum Age: 10 years and older at selected sites
- Being tested
- BMS-906024, Dexamethasone
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-906024Drug
Also called Notch inhibitor
DexamethasoneDrug
Also called Baycadron
| Study group | Role | What they receive |
|---|---|---|
| Escalation Phase: BMS-906024 | Experimental | BMS-906024 escalating doses starting at 0.3 mg solution for intravenous (IV) administration once weekly continuously until disease progression or unacceptable toxicity Receives: Drug: BMS-906024 |
| Expansion Phase: BMS-906024 + Dexamethasone | Experimental | BMS-906024 maximum tolerated dose (To be determined) solution for IV administration once weekly and Dexamethasone 20mg/day tablet by mouth (Oral) for 3-4 days every week for 3-4 weeks per cycle continuously until disease progression or unacceptable toxicity Receives: Drug: BMS-906024; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events as a measure of safety and tolerability
Measured: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse events as well as an assessment 30 days after treatment discontinuation with an average time on study expected to be < 1 year.
Secondary outcomes (8)
Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI)
Measured: Disease assessments at least every 8 weeks during treatment
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: maximum observed concentration (Cmax)
Measured: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: minimum observed concentration (Cmin)
Measured: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: area under the concentration-time curve (AUC)
Measured: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: time to reach maximum observed concentration (Tmax)
Measured: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: terminal phase elimination half-life (T-Half)
Measured: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: accumulation index (ratio of AUC at steady state to AUC after first dose)
Measured: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacodynamics (percent change from baseline in mRNA expression of Notch pathway-related genes in blood cells)
Measured: Pharmacodynamic sampling: in blood during the first 8 weeks of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study start28 Sep 2011
- Primary completion7 Feb 2018
- Study completion7 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic Leukemia, Acute T-cellStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363817
- Sponsor's protocol ID
- CA216-002
- Other IDs
- 2010-022727-29
- Status last verified
- Jul 2019
- First submitted
- 22 Apr 2011
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT01363817
- Acronym / sponsor ID
- CA216-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2011 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 7 Feb 2018 (actual)
- First posted
- 2 Jun 2011 (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 identify a safe and tolerable dose of BMS-906024, either alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies
Detailed description
Minimum Age: 10 years and older at selected sites
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escalation Phase: BMS-906024 | Experimental | Drug: BMS-906024BMS-906024 escalating doses starting at 0.3 mg solution for intravenous (IV) administration once weekly continuously until disease progression or unacceptable toxicity |
| Expansion Phase: BMS-906024 + Dexamethasone | Experimental | Drug: BMS-906024, Drug: DexamethasoneBMS-906024 maximum tolerated dose (To be determined) solution for IV administration once weekly and Dexamethasone 20mg/day tablet by mouth (Oral) for 3-4 days every week for 3-4 weeks per cycle continuously until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma refractory to or relapsed from standard therapies
- Life expectancy of at least 2 months
- Performance status (PS) 0-1 (a measure of the ability to carry out activities of daily living); subjects with PS 2 are eligible if due to disease related symptoms
- Prior anti-cancer treatment permitted (with specific criteria)
- Adequate organ function
Key exclusion criteria (5 listed)
- Infection
- Elevated triglycerides
- Gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
- Unable to tolerate bone marrow biopsy
- Taking medications known to increase risk of Torsades De Pointes (an abnormal heart rhythm)
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 |
|---|---|---|
| BMS-906024Also: Notch inhibitor | Drug | Escalation Phase: BMS-906024, Expansion Phase: BMS-906024 + Dexamethasone |
| DexamethasoneAlso: Baycadron | Drug | Expansion Phase: BMS-906024 + Dexamethasone |
Primary outcome
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse events as well as an assessment 30 days after treatment discontinuation with an average time on study expected to be < 1 year.
8 secondary outcomes
Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI)
Time frame: Disease assessments at least every 8 weeks during treatment
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: maximum observed concentration (Cmax)
Time frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: minimum observed concentration (Cmin)
Time frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: area under the concentration-time curve (AUC)
Time frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: time to reach maximum observed concentration (Tmax)
Time frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: terminal phase elimination half-life (T-Half)
Time frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: accumulation index (ratio of AUC at steady state to AUC after first dose)
Time frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacodynamics (percent change from baseline in mRNA expression of Notch pathway-related genes in blood cells)
Time frame: Pharmacodynamic sampling: in blood during the first 8 weeks of dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
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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
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-906024 and Dexamethasone in people with Lymphoblastic Leukemia, Acute T-cell and Precursor T-Cell Lymphoblastic Lymphoma, run by Bristol-Myers Squibb at 6 sites in 3 countries.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France, Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with adverse events as a measure of safety and tolerability (time frame: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse events as well as an assessment 30 days after treatment discontinuation with an average time on study expected to be < 1 year.). 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 30 Jul 2019.