LeukemiaPhase 1/2NCT02305563
An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 1/2 study testing BMS-936564 and Cytarabine in people with Leukemia, run by Bristol-Myers Squibb at 38 sites in 10 countries.
Trial summary
The purpose of this study is to determine the safety and effectiveness of ulocuplumab in combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid Leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- BMS-936564 and Cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 38 sitesin 10 countries
- Study dates
- 27 Jan 2015to 4 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Newly Diagnosed Acute Myeloid Leukemia (AML)
- Considered inappropriate for intensive remission induction therapy by an investigator
- Not eligible for stem cell transplantation
Who cannot join
- Acute promyelocytic leukemia
- Current Myelodysplastic syndrome only subjects
- Unstable angina or uncontrolled congestive heart failure
- Any other malignancy, excluding basal or squamous cell carcinoma of the skin, in situ melanoma, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years
- Respiratory disease requiring continuous supplemental oxygen
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
38 sites in 10 countries.
38 sites in 10 countries
United States9 sites
University Of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Duke University Adult Bone Marrow Transplant Clinic
Durham, North Carolina, 27705
The University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Ucla Center Health Sci
Los Angeles, California, 90095-3075
Norton Cancer Institute
Louisville, Kentucky, 40207
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
NYU Langone Medical Center
New York, New York, 10016
UF Health Cancer Center at Orlando Health
Orlando, Florida, 32806
Japan8 sites
Local Institution
Bunkyo-ku, Tokyo, 1138677
Local Institution
Fukuyama-shi, Hiroshima, 7200001
Local Institution
Hirakata-shi, Osaka, 5731191
Local Institution
Isehara, Kanagawa, 2591193
Local Institution
Nagoya, Aichi-ken, 4600001
Local Institution
Shinagawa-ku, Tokyo, 1418625
Local Institution
Shinjuku-Ku, Tokyo, 1608582
Local Institution
Tachikawa, Tokyo, 1900014
Brazil6 sites
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos, São Paulo, 14784-400
Liga Paranaense De Combate Ao Cancer Erasto Gaertner
Curitiba, Paraná, 81520-060
Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
Porto Alegre, Rio Grande do Sul, 90110-270
IEP Sao Lucas
São Paulo, 01236-030
Local Institution
São Paulo, 01246-000
Local Institution
São Paulo, 05651-901
Italy4 sites
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, 95123
Local Institution
Milan, 20162
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
Naples, 80131
Local Institution
Roma, 00133
Taiwan4 sites
Local Institution
Kaohsiung City, 833
Local Institution
New Taipei City, 235
Local Institution
New Taipei City, 25173
Local Institution
Taoyuan City, 33305
Israel2 sites
Local Institution
Jerusalem, 91031
Local Institution
Tel Aviv, 94239
South Korea2 sites
Local Institution
Seoul, 06351
Local Institution
Seoul, 06591
About this study
Official title: A Phase 1/2, Open-label Randomized Study of Ulocuplumab (BMS-936564) in Combination With Low Dose Cytarabine in Subjects With Newly Diagnosed Acute Myeloid Leukemia
The purpose of this study is to determine the safety and effectiveness of ulocuplumab in combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid Leukemia (AML).
- Conditions
- Leukemia
- Being tested
- BMS-936564, Cytarabine
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-936564Drug
Also called Ulocuplumab, MDX-1338
CytarabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Ulocuplumab + low dose Cytarabine | Experimental | Ulocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment Receives: Drug: BMS-936564; Drug: Cytarabine |
| Ulocuplumab Dose A + low dose Cytarabine | Experimental | Ulocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort) Receives: Drug: BMS-936564; Drug: Cytarabine |
| Ulocuplumab Dose B + low dose Cytarabine | Experimental | Ulocuplumab Dose B + low dose Cytarabine Phase 2 (expansion cohort) Receives: Drug: BMS-936564; Drug: Cytarabine |
| low dose Cytarabine only | Other | Low Dose Cytarabine only Phase 2 (expansion cohort) Receives: Drug: BMS-936564; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1
Safety data evaluated for DLTs. DLTs and all other toxicities were defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). DLTs were defined based upon events that were considered to be related to ulocuplumab in combination with LDAC and that occurred during the first cycle of drug administration (28 days).
Measured: From first dose to end of cycle 1 (28 days)
Number of Participants With Adverse Events (AEs) - Phase 1
The number of participants with an on-study adverse event (AE).
Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Measured: From first dose to 30 days post last dose
Number of Participants With >= Grade 3 AEs - Phase 1
The number of participants with an on-study adverse event >= Grade level 3.
Safety data are evaluated for >= Grade 3 AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Measured: From first dose to 30 days post last dose
Number of Participants With AEs Leading to Discontinuation - Phase 1
The number of participants with an on-study adverse event (AE) leading to discontinuation.
Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Measured: From first dose to 30 days post last dose
Number of Participants With Serious Adverse Events (SAEs) - Phase 1
The number of participants with an on-study serious adverse event (SAE).
Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Measured: From first dose to 30 days post last dose
Number of Deaths - Phase 1
The number of participants who died.
Measured: From first dose to 30 days post last dose
Number of Participants With Laboratory Abnormalities - Phase 1
The number of participants with an on-study laboratory abnormality.
Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
grades 1, 2, 3, 4, 5, unknown, with 5 being the worst outcome
Measured: From first dose to 30 days post last dose
Best Overall Response (BOR) - Phase 2
The phase 2 primary endpoint was based on the rate of Complete Remission (CR/CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 primary analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Complete remission rate: CR + CRi, confidence interval based on the Clopper and Pearson method.
CR = complete response CRi = complete response, incomplete blood count
Measured: From first dose until a minimum follow-up of up to 2 months
Secondary outcomes (25)
Best Overall Response (BOR) - Phase 1
Investigator assessed best overall response prior to the initiation of any alternative therapy for Phase 1 participants.
Measured: From first dose until a minimum follow-up of up to 2 months
Number of Participants With AEs - Phase 2
The number of participants with an on-study adverse event (AE).
Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Measured: From first dose until a minimum follow-up of up to 2 months
Number of Participants With AEs Leading to Discontinuation - Phase 2
The number of participants with an on-study adverse event (AE) leading to discontinuation.
Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Measured: From first dose until a minimum follow-up of up to 2 months
Number of Participants With SAEs - Phase 2
The number of participants with an on-study serious adverse event (SAE).
Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Measured: From first dose until a minimum follow-up of up to 2 months
Number of Deaths- Phase 2
The number of participants who died.
Safety data are evaluated for deaths, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Measured: From first dose until a minimum follow-up of up to 2 months
Number of Participants With Laboratory Abnormalities - Phase 2
The number of participants with an on-study laboratory abnormality, assessed from Grade 1-4 Serum Chemistry, Electrolytes, and Hematology Laboratory Test results, with grade 4 being the worst.
Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Measured: From first dose until a minimum follow-up of up to 2 months
Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2
Serum samples from ulocuplumab treated participants were evaluated for the presence of anti-ulocuplumab antibodies
Measured: From first dose until a minimum follow-up of up to 2 months
Maximum Observed Serum Concentration (Cmax) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration
EOT = end of treatment
Measure type and method of dispersion are Geometric mean and %CV, respectively
Measured: Cycle 1 Day 1
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
Measure type and method of dispersion are Geometric mean and %CV, respectively
Measured: Days 1, 8, 15 for cycle 1; Days 8, 15 for cycle 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Time of Maximum Observed Ulocuplumab Serum Concentration (Tmax) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
Measured: Cycle 1 Day 1
Area Under the Ulocuplumab Concentration-time Curve From Time Zero to the Last Quantifiable Concentration [AUC(0-T)] - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
AUC(0-T) calculated by log- and linear-trapezoidal summation
Measure type and method of dispersion are Geometric mean and %CV, respectively
Measured: Cycle 1 Day 1
Area Under the Ulocuplumab Concentration-time Curve in One Dosing Interval [AUC(TAU)] - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
Measure type and method of dispersion are Geometric mean and %CV, respectively
Measured: Cycle 1 Day 1
Area Under the Ulocuplumab Concentration-time Curve From Time Zero to Infinity [AUC(INF)] - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
AUC(INF) calculated by summing AUC(0-T) and the extrapolated area, computed by the quotient Clast/λz
Measure type and method of dispersion are Geometric mean and %CV, respectively
Measured: Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Elimination Half-life (T-HALF) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
T-HALF determined as 0.693/λz
Measured: Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Total Body Clearance of Ulocuplumab (CLT) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
CLT calculated by dividing the total dose of ulocuplumab by its corresponding AUC(INF) value
Measure type and method of dispersion are Geometric mean and %CV, respectively
Measured: Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Volume of Distribution at Steady State (Vss) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
Measure type and method of dispersion are Geometric mean and %CV, respectively
Measured: Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Overall Rate of Remission in Participants Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2
This phase 2 secondary endpoint was based on the rate of Overall Remission (OR=PR+CR +CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Overall remission rate: CR + CRi, + PR confidence interval based on the Clopper and Pearson method.
CR = complete response CRi = complete response, incomplete blood count PR = partial remission
Measured: From first dose until a minimum follow-up of up to 2 months
Duration of Response in Participants With CR/CRi Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2
This phase 2 secondary endpoint was based on the duration of complete remission prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Measured: From first dose until a minimum follow-up of up to 2 months
Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2
This phase 2 secondary endpoint was based on the rate of Complete Remission (CR/CRi) and rate of Overall Remission (OR=PR+CR +CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Overall remission rate: CR + CRi, + PR confidence interval based on the Clopper and Pearson method.
CR = complete response CRi = complete response, incomplete blood count PR = partial remission
Measured: From first dose until a minimum follow-up of up to 2 months
Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2
This phase 2 secondary endpoint was based on the duration of complete remission prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Measured: From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Change from baseline of ECG endpoints
Heart rate measured in beats per minute (bpm)
Measured: From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Change from baseline of ECG endpoints
PR interval measured in milliseconds (msec)
Measured: From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Change from baseline of ECG endpoints
QRS interval measured in milliseconds (msec)
Measured: From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Change from baseline of ECG endpoints
QT interval measured in milliseconds (msec)
Measured: From first dose until a minimum follow-up of up to 2 months
Overall Survival (OS) - Phases 1 and 2
OS is defined as the time between the first date of treatment and the date of death due to any cause. A participant who has not died was be censored at the last known alive date.
Measured: From first dose until a minimum follow-up of up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start27 Jan 2015
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
Why it stopped: Business objectives have changed, slow accrual, the standard of care for the patient population changed and we were unable to accrue any longer.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT02305563
- Sponsor's protocol ID
- CA212-016
- Status last verified
- Aug 2021
- First submitted
- 27 Nov 2014
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label Randomized Study of Ulocuplumab (BMS-936564) in Combination With Low Dose Cytarabine in Subjects With Newly Diagnosed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02305563
- Acronym / sponsor ID
- CA212-016
- Conditions
- Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed, slow accrual, the standard of care for the patient population changed and we were unable to accrue any longer.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Posted 16 Sep 2021
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 safety and effectiveness of ulocuplumab in combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid Leukemia (AML).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ulocuplumab + low dose Cytarabine | Experimental | Drug: BMS-936564, Drug: CytarabineUlocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment |
| Ulocuplumab Dose A + low dose Cytarabine | Experimental | Drug: BMS-936564, Drug: CytarabineUlocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort) |
| Ulocuplumab Dose B + low dose Cytarabine | Experimental | Drug: BMS-936564, Drug: CytarabineUlocuplumab Dose B + low dose Cytarabine Phase 2 (expansion cohort) |
| low dose Cytarabine only | Other | Drug: BMS-936564, Drug: CytarabineLow Dose Cytarabine only Phase 2 (expansion cohort) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly Diagnosed Acute Myeloid Leukemia (AML)
- Considered inappropriate for intensive remission induction therapy by an investigator
- Not eligible for stem cell transplantation
Key exclusion criteria (6 listed)
- Acute promyelocytic leukemia
- Current Myelodysplastic syndrome only subjects
- Unstable angina or uncontrolled congestive heart failure
- Any other malignancy, excluding basal or squamous cell carcinoma of the skin, in situ melanoma, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years
- Respiratory disease requiring continuous supplemental oxygen
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-936564Also: Ulocuplumab, MDX-1338 | Drug | Ulocuplumab + low dose Cytarabine, Ulocuplumab Dose A + low dose Cytarabine, Ulocuplumab Dose B + low dose Cytarabine, low dose Cytarabine only |
| Cytarabine | Drug | Ulocuplumab + low dose Cytarabine, Ulocuplumab Dose A + low dose Cytarabine, Ulocuplumab Dose B + low dose Cytarabine, low dose Cytarabine only |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1
Time frame: From first dose to end of cycle 1 (28 days)
Safety data evaluated for DLTs. DLTs and all other toxicities were defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). DLTs were defined based upon events that were considered to be related to ulocuplumab in combination with LDAC and that occurred during the first cycle of drug administration (28 days).
Number of Participants With Adverse Events (AEs) - Phase 1
Time frame: From first dose to 30 days post last dose
The number of participants with an on-study adverse event (AE). Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Number of Participants With >= Grade 3 AEs - Phase 1
Time frame: From first dose to 30 days post last dose
The number of participants with an on-study adverse event >= Grade level 3. Safety data are evaluated for >= Grade 3 AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Number of Participants With AEs Leading to Discontinuation - Phase 1
Time frame: From first dose to 30 days post last dose
The number of participants with an on-study adverse event (AE) leading to discontinuation. Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Number of Participants With Serious Adverse Events (SAEs) - Phase 1
Time frame: From first dose to 30 days post last dose
The number of participants with an on-study serious adverse event (SAE). Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Number of Deaths - Phase 1
Time frame: From first dose to 30 days post last dose
The number of participants who died.
Number of Participants With Laboratory Abnormalities - Phase 1
Time frame: From first dose to 30 days post last dose
The number of participants with an on-study laboratory abnormality. Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). grades 1, 2, 3, 4, 5, unknown, with 5 being the worst outcome
Best Overall Response (BOR) - Phase 2
Time frame: From first dose until a minimum follow-up of up to 2 months
The phase 2 primary endpoint was based on the rate of Complete Remission (CR/CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 primary analysis was conducted after all participants had an opportunity for 6 months of follow-up. Complete remission rate: CR + CRi, confidence interval based on the Clopper and Pearson method. CR = complete response CRi = complete response, incomplete blood count
25 secondary outcomes
Best Overall Response (BOR) - Phase 1
Time frame: From first dose until a minimum follow-up of up to 2 months
Number of Participants With AEs - Phase 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Number of Participants With AEs Leading to Discontinuation - Phase 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Number of Participants With SAEs - Phase 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Number of Deaths- Phase 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Number of Participants With Laboratory Abnormalities - Phase 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Maximum Observed Serum Concentration (Cmax) - Phases 1 and 2
Time frame: Cycle 1 Day 1
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Time frame: Days 1, 8, 15 for cycle 1; Days 8, 15 for cycle 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Time of Maximum Observed Ulocuplumab Serum Concentration (Tmax) - Phases 1 and 2
Time frame: Cycle 1 Day 1
Area Under the Ulocuplumab Concentration-time Curve From Time Zero to the Last Quantifiable Concentration [AUC(0-T)] - Phases 1 and 2
Time frame: Cycle 1 Day 1
Area Under the Ulocuplumab Concentration-time Curve in One Dosing Interval [AUC(TAU)] - Phases 1 and 2
Time frame: Cycle 1 Day 1
Area Under the Ulocuplumab Concentration-time Curve From Time Zero to Infinity [AUC(INF)] - Phases 1 and 2
Time frame: Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Elimination Half-life (T-HALF) - Phases 1 and 2
Time frame: Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Total Body Clearance of Ulocuplumab (CLT) - Phases 1 and 2
Time frame: Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Volume of Distribution at Steady State (Vss) - Phases 1 and 2
Time frame: Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Overall Rate of Remission in Participants Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Duration of Response in Participants With CR/CRi Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Overall Survival (OS) - Phases 1 and 2
Time frame: From first dose until a minimum follow-up of up to 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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
38 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-936564 and Cytarabine in people with Leukemia, run by Bristol-Myers Squibb at 38 sites in 10 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Japan, Brazil, Italy, Taiwan and 5 more countries. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1 (time frame: From first dose to end of cycle 1 (28 days)). The study lists 8 primary outcomes in all. 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 16 Sep 2021.