A Phase 1/2 interventional study of BMS-936564 and Cytarabine in Leukemia, sponsored by Bristol-Myers Squibb. Terminated at 38 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment
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).
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 70 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Ulocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment
Drug: BMS-936564 · Drug: Cytarabine
Ulocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort)
Drug: BMS-936564 · Drug: Cytarabine
Ulocuplumab Dose B + low dose Cytarabine Phase 2 (expansion cohort)
Drug: BMS-936564 · Drug: Cytarabine
Low Dose Cytarabine only Phase 2 (expansion cohort)
Drug: BMS-936564 · Drug: Cytarabine
Also known as: Ulocuplumab, MDX-1338
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: From first dose to 30 days post last dose
Number of Deaths - Phase 1
The number of participants who died.
Time frame: 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
Time frame: 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
Time frame: From first dose until a minimum follow-up of up to 2 months
Best Overall Response (BOR) - Phase 1
Investigator assessed best overall response prior to the initiation of any alternative therapy for Phase 1 participants.
Time frame: 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).
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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
Serum samples from ulocuplumab treated participants were evaluated for the presence of anti-ulocuplumab antibodies
Time frame: 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
Time frame: 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
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
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment
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
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
Time frame: 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
Time frame: 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
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
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment T-HALF determined as 0.693/λz
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
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
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
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
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
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
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
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.
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
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
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
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.
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
Change from baseline of ECG endpoints Heart rate measured in beats per minute (bpm)
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
Change from baseline of ECG endpoints PR interval measured in milliseconds (msec)
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
Change from baseline of ECG endpoints QRS interval measured in milliseconds (msec)
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
Change from baseline of ECG endpoints QT interval measured in milliseconds (msec)
Time frame: 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.
Time frame: From first dose until a minimum follow-up of up to 2 months
| Milestone | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Started | 3 | 3 | 26 | 14 | 24 |
| Completed | 1 | 1 | 0 | 0 | 0 |
| Not completed | 2 | 2 | 26 | 14 | 24 |
| Withdrew: Disease progression | 0 | 0 | 15 | 6 | 6 |
| Withdrew: Study drug toxicity | 0 | 0 | 0 | 1 | 2 |
| Withdrew: Death | 0 | 0 | 1 | 2 | 1 |
| Withdrew: Adverse event (ae) unrelated to drug | 0 | 0 | 7 | 1 | 2 |
| Withdrew: Participant request to stop therapy | 0 | 2 | 0 | 1 | 0 |
| Withdrew: Participant withdrew consent | 0 | 0 | 1 | 1 | 1 |
| Withdrew: Maximum clinical benefit | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Poor/non-compliance | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Administrative reason by sponsor | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Other reason | 2 | 0 | 2 | 2 | 1 |
| Withdrew: Randomized but not treated | 0 | 0 | 0 | 0 | 2 |
| Withdrew: Added ulo, then disease progression | 0 | 0 | 0 | 0 | 4 |
| Withdrew: Added ulo; then other reason | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Added ulo, then request to stop | 0 | 0 | 0 | 0 | 1 |
| Milestone | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Started | 3 | 3 | 11 | 6 | 12 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 3 | 3 | 11 | 6 | 12 |
| Withdrew: Death | 0 | 0 | 5 | 4 | 7 |
| Withdrew: Participant withdrew consent | 0 | 0 | 2 | 1 | 0 |
| Withdrew: Other reason | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Followup no longer required per protocol | 3 | 3 | 4 | 1 | 4 |
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).
| Participants | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1 | 0 | 0 |
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).
| Participants | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
|---|---|---|
| Number of Participants With Adverse Events (AEs) - Phase 1 | 3 | 3 |
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).
| Participants | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
|---|---|---|
| Number of Participants With >= Grade 3 AEs - Phase 1 | 3 | 3 |
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).
| Participants | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
|---|---|---|
| Number of Participants With AEs Leading to Discontinuation - Phase 1 | 0 | 0 |
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).
| Participants | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) - Phase 1 | 2 | 1 |
The number of participants who died.
| Participants | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
|---|---|---|
| Number of Deaths - Phase 1 | 0 | 0 |
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
| Participants | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
|---|---|---|
| ABSOLUTE NEUTROPHIL COUNT - grade 3 | 0 | 1 |
| ABSOLUTE NEUTROPHIL COUNT - grade 4 | 3 | 2 |
| ALANINE AMINOTRANSFERASE - grade 0 | 2 | 2 |
| ALANINE AMINOTRANSFERASE - grade 1 | 1 | 1 |
| ALBUMIN - grade 0 | 1 | 0 |
| ALBUMIN - grade 1 | 0 | 2 |
| ALBUMIN - grade 2 | 2 | 1 |
| ALKALINE PHOSPHATASE - grade 0 | 2 | 2 |
| ALKALINE PHOSPHATASE grade 1 | 1 | 1 |
| ASPARTATE AMINOTRANSFERASE - grade 0 | 3 | 2 |
| ASPARTATE AMINOTRANSFERASE - grade 1 | 0 | 1 |
| BILIRUBIN, TOTAL - grade 0 | 3 | 2 |
| BILIRUBIN, TOTAL - grade 2 | 0 | 1 |
| CALCIUM, TOTAL - grade 0 | 1 | 1 |
| CALCIUM, TOTAL - grade 1 | 0 | 1 |
| CALCIUM, TOTAL - grade 2 | 2 | 1 |
| CREATINE KINASE - grade 0 | 3 | 3 |
| CREATININE - grade 0 | 2 | 3 |
| CREATININE - grade 1 | 1 | 0 |
| FIBRINOGEN - grade 0 | 1 | 0 |
| GLUCOSE, FASTING SERUM - grade 0 | 1 | 1 |
| GLUCOSE, FASTING SERUM - grade 1 | 2 | 0 |
| GLUCOSE, FASTING SERUM - grade 2 | 0 | 2 |
| HEMOGLOBIN - grade 2 | 1 | 1 |
| HEMOGLOBIN - grade 3 | 2 | 2 |
| LEUKOCYTES - grade 0 | 0 | 1 |
| LEUKOCYTES - grade 3 | 1 | 1 |
| LEUKOCYTES - grade 4 | 2 | 1 |
| LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 0 | 2 | 1 |
| LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 1 | 1 | 0 |
| LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 3 | 0 | 2 |
| LYMPHOCYTES (ABSOLUTE) - grade 0 | 0 | 1 |
| LYMPHOCYTES (ABSOLUTE) - grade 1 | 0 | 1 |
| LYMPHOCYTES (ABSOLUTE) - grade 2 | 2 | 1 |
| LYMPHOCYTES (ABSOLUTE) - grade 3 | 1 | 0 |
| NEUTROPHILS (ABSOLUTE) - grade 3 | 0 | 1 |
| NEUTROPHILS (ABSOLUTE) - grade 4 | 3 | 2 |
| PHOSPHORUS, INORGANIC - grade 0 | 3 | 2 |
| PHOSPHORUS, INORGANIC - grade 3 | 0 | 1 |
| PLATELET COUNT - grade 3 | 0 | 1 |
| PLATELET COUNT - grade 4 | 3 | 2 |
| POTASSIUM, SERUM - grade 0 | 1 | 2 |
| POTASSIUM, SERUM - grade 1 | 0 | 1 |
| POTASSIUM, SERUM - grade 3 | 2 | 0 |
| SODIUM, SERUM - grade 0 | 2 | 1 |
| SODIUM, SERUM - grade 1 | 0 | 2 |
| SODIUM, SERUM - grade 3 | 1 | 0 |
| URIC ACID - grade 0 | 3 | 2 |
| URIC ACID - grade 1 | 0 | 1 |
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
| Percentage of participants | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|
| Best Overall Response (BOR) - Phase 2 | 15.4 (4.4 to 34.9) | 7.1 (0.2 to 33.9) | 25.0 (9.8 to 46.7) |
Investigator assessed best overall response prior to the initiation of any alternative therapy for Phase 1 participants.
| Participants | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
|---|---|---|
| Best Overall Response (BOR) - Phase 1 | 1 | 3 |
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).
| Participants | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|
| Number of Participants With AEs - Phase 2 | 25 | 14 | 22 |
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).
| Participants | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|
| Number of Participants With AEs Leading to Discontinuation - Phase 2 | 7 | 3 | 4 |
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).
| Participants | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|
| Number of Participants With SAEs - Phase 2 | 21 | 8 | 15 |
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).
| Participants | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|
| Number of Deaths- Phase 2 | 19 | 10 | 16 |
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).
| Participants | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|
| ALANINE AMINOTRANSFERASE (ALT), grade 1 | 5 | 5 | 4 |
| ALANINE AMINOTRANSFERASE (ALT), grade 2 | 0 | 1 | 2 |
| ALANINE AMINOTRANSFERASE (ALT), grade 3 | 2 | 2 | 0 |
| ALKALINE PHOSPHATASE (ALP), grade 1 | 9 | 3 | 8 |
| ALKALINE PHOSPHATASE (ALP), grade 2 | 1 | 5 | 2 |
| ASPARTATE AMINOTRANSFERASE (AST), grade 1 | 7 | 8 | 4 |
| ASPARTATE AMINOTRANSFERASE (AST), grade 2 | 1 | 0 | 2 |
| ASPARTATE AMINOTRANSFERASE (AST), grade 3 | 0 | 1 | 0 |
| BILIRUBIN, TOTAL, grade 1 | 3 | 2 | 1 |
| BILIRUBIN, TOTAL, grade 2 | 4 | 3 | 1 |
| BILIRUBIN, TOTAL, grade 3 | 1 | 0 | 0 |
| CREATININE, grade 1 | 7 | 5 | 6 |
| CREATININE, grade 2 | 5 | 2 | 2 |
| CALCIUM, TOTAL, grade 1 | 7 | 3 | 3 |
| CALCIUM, TOTAL, grade 2 | 5 | 5 | 7 |
| CALCIUM, TOTAL, grade 3 | 0 | 1 | 0 |
| PHOSPHORUS, INORGANIC, grade 1 | 0 | 0 | 1 |
| PHOSPHORUS, INORGANIC, grade 2 | 3 | 2 | 1 |
| PHOSPHORUS, INORGANIC, grade 3 | 2 | 0 | 2 |
| PHOSPHORUS, INORGANIC, grade 4 | 0 | 1 | 0 |
| POTASSIUM, SERUM, grade 1 | 4 | 3 | 5 |
| POTASSIUM, SERUM, grade 2 | 0 | 1 | 0 |
| POTASSIUM, SERUM, grade 3 | 1 | 2 | 4 |
| POTASSIUM, SERUM, grade 4 | 1 | 1 | 0 |
| SODIUM, SERUM, grade 1 | 9 | 3 | 7 |
| SODIUM, SERUM, grade 2 | 0 | 1 | 0 |
| SODIUM, SERUM, grade 3 | 0 | 3 | 4 |
| HEMOGLOBIN, grade 2 | 2 | 4 | 4 |
| HEMOGLOBIN, grade 3 | 22 | 10 | 17 |
| PLATELET COUNT, grade 2 | 0 | 0 | 1 |
| PLATELET COUNT, grade 3 | 1 | 1 | 3 |
| PLATELET COUNT, grade 4 | 23 | 13 | 17 |
| ABSOLUTE NEUTROPHIL COUNT, grade 1 | 2 | 1 | 0 |
| ABSOLUTE NEUTROPHIL COUNT, grade 2 | 0 | 1 | 1 |
| ABSOLUTE NEUTROPHIL COUNT, grade 3 | 3 | 0 | 1 |
| ABSOLUTE NEUTROPHIL COUNT, grade 4 | 18 | 10 | 16 |
| LEUKOCYTES, grade 1 | 3 | 0 | 1 |
| LEUKOCYTES, grade 2 | 3 | 4 | 0 |
| LEUKOCYTES, grade 3 | 6 | 4 | 5 |
| LEUKOCYTES, grade 4 | 8 | 1 | 10 |
| LYMPHOCYTES (ABSOLUTE), grade 1 | 3 | 4 | 1 |
| LYMPHOCYTES (ABSOLUTE), grade 2 | 7 | 1 | 7 |
| LYMPHOCYTES (ABSOLUTE), grade 3 | 5 | 0 | 7 |
| LYMPHOCYTES (ABSOLUTE), grade 4 | 0 | 0 | 1 |
| NEUTROPHILS (ABSOLUTE), grade 1 | 1 | 0 | 0 |
| NEUTROPHILS (ABSOLUTE), grade 2 | 1 | 2 | 1 |
| NEUTROPHILS (ABSOLUTE), grade 3 | 3 | 0 | 1 |
| NEUTROPHILS (ABSOLUTE), grade 4 | 18 | 10 | 16 |
Serum samples from ulocuplumab treated participants were evaluated for the presence of anti-ulocuplumab antibodies
| Participants | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 |
|---|---|---|---|---|
| Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2 | 0 | 0 | 6 | 0 |
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
| µg/mL | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Maximum Observed Serum Concentration (Cmax) - Phases 1 and 2 | 219.354 ± 19 | 265.294 ± 8 | 183.456 ± 25 | 256.906 ± 22 | 212.564 ± NA |
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
| µg/mL | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Cycle 1 Day 1 | 0.100 ± 0 | 0.100 ± 0 | 0.100 ± 0 | 0.100 ± 0 | 0.100 ± NA |
| Cycle 1 Day 8 | 5.308 ± 89 | 75.890 ± 30 | 10.321 ± 85 | 17.766 ± 79 | 39.609 ± NA |
| Cycle 1 Day 15 | 21.748 ± 91 | 125.797 ± 18 | 37.263 ± 66 | 61.250 ± 64 | 175.315 ± NA |
| Cycle 2 Day 8 | 41.630 ± NA | 96.333 ± 36 | 30.916 ± 83 | 103.322 ± 67 | — |
| Cycle 2 Day 15 | 72.104 ± NA | 126.029 ± 49 | 48.421 ± 73 | 143.724 ± 58 | — |
| Cycle 3 Day 1 | — | 78.218 ± NA | 13.905 ± 101 | 153.871 ± 70 | — |
| Cycle 3 Day 8 | 85.993 ± NA | 129.580 ± 42 | 37.602 ± 94 | 82.033 ± 21 | — |
| Cycle 4 Day 1 | — | 80.409 ± 64 | 4.012 ± 145 | 212.793 ± NA | — |
| Cycle 4 Day 8 | 112.048 ± NA | 133.650 ± 41 | 116.657 ± 83 | 77.095 ± 119 | — |
| Cycle 5 Day 1 | — | 32.621 ± NA | 4.558 ± 166 | 224.703 ± NA | — |
| Cycle 5 Day 8 | 102.751 ± NA | 124.996 ± 48 | 34.783 ± 137 | 202.552 ± NA | — |
| Cycle 9 Day 1 | — | — | 35.144 ± 110 | 187.930 ± NA | — |
| EOT | — | — | 0.100 ± NA | — | — |
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment
| hour (H) | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Time of Maximum Observed Ulocuplumab Serum Concentration (Tmax) - Phases 1 and 2 | 1.850 (1.47 to 2.02) | 1.933 (1.68 to 2.03) | 1.500 (1.00 to 4.50) | 2.117 (1.28 to 5.12) | 2.03 (2.03 to 2.03) |
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
| µg.h/mL | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Area Under the Ulocuplumab Concentration-time Curve From Time Zero to the Last Quantifiable Concentration [AUC(0-T)] - Phases 1 and 2 | 9455.529 ± 10 | 21158.725 ± 9 | 8152.698 ± 50 | 13744.382 ± 37 | 16502.463 ± NA |
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
| µg.h/mL | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Area Under the Ulocuplumab Concentration-time Curve in One Dosing Interval [AUC(TAU)] - Phases 1 and 2 | 9455.529 ± 10 | 21158.725 ± 9 | 10082.624 ± 38 | 13826.833 ± 36 | 14257.807 ± NA |
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
No measurements were reported for this outcome.
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment T-HALF determined as 0.693/λz
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
| Percentage of participants | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 |
|---|---|---|
| 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 | 19.2 (6.6 to 39.4) | 7.1 (0.2 to 33.9) |
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.
| Months | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 |
|---|---|---|
| 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 | 2.4 (0.5 to 5.6) | 4.3 (NA to NA) |
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
| Percentage of participants | LDAC - Ph2 |
|---|---|
| CR/CRi | 25.0 (9.8 to 46.7) |
| Overall remission rate | 25.0 (9.8 to 46.7) |
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.
| Months | LDAC - Ph2 |
|---|---|
| Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2 | 5.7 (0.9 to NA) |
Change from baseline of ECG endpoints Heart rate measured in beats per minute (bpm)
| change from baseline bpm | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Cycle 2 Day 1 | 26.0 ± 63.6 | 4.0 ± 18.4 | 1.8 ± 11.3 | -0.9 ± 20.0 | -3.0 ± 7.6 |
| Cycle 3, Day 1 | -2.3 ± 18.8 | 0.0 ± 15.6 | 5.8 ± 14.2 | 12.7 ± 14.3 | 1.7 ± 10.2 |
| Cycle 4, Day 1 | -1.0 | -16.0 ± 5.7 | -0.1 ± 9.9 | 11.0 ± 40.6 | 1.3 ± 16.7 |
| Cycle 5, Day 1 | -6.0 | 1.5 ± 7.8 | 4.3 ± 12.3 | 10.5 ± 2.1 | 8.8 ± 27.5 |
| Cycle 6, Day 1 | -6.0 | -6.0 ± 16.5 | 6.8 ± 5.3 | — | 7.4 ± 14.9 |
| Cycle 7, Day 1 | — | -11.7 ± 18.6 | -3.5 ± 5.9 | 12.0 ± NA | 6.5 ± 13.5 |
| Cycle 8, Day 1 | -1.0 | — | 0.7 ± 2.1 | 11.0 ± NA | 0.8 ± 11.4 |
| Cycle 9, Day 1 | — | -17.0 ± 11.3 | 7.0 ± 7.1 | 3.0 ± NA | 0.6 ± 8.9 |
| Cycle 10, Day 1 | -3.0 | -16.0 ± NA | 9.3 ± 5.1 | — | 2.0 ± 1.4 |
| Cycle 11, Day 1 | -12.0 | — | — | 10.0 ± NA | -0.3 ± 6.7 |
| Cycle 12, Day 1 | — | — | 5.0 ± NA | 19.0 ± NA | 7.0 ± 2.8 |
| Cycle 13, Day 1 | -9.0 | — | 8.0 ± NA | — | 4.0 ± 2.8 |
| Cycle 14, Day 1 | — | — | 14.0 ± NA | — | — |
| Cycle 15, Day 1 | -10.0 | — | — | — | 8.0 ± NA |
| Cycle 16, Day 1 | — | — | — | — | 18.0 ± NA |
Change from baseline of ECG endpoints PR interval measured in milliseconds (msec)
| change from baseline msec | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Cycle 2 Day 1 | 4.0 ± NA | -14.0 ± 19.8 | 1.1 ± 23.9 | -5.1 ± 9.9 | 1.2 ± 5.3 |
| Cycle 3, Day 1 | 8.0 ± 6.0 | -12.0 ± 0.0 | -5.3 ± 26.2 | -2.8 ± 8.4 | -1.9 ± 7.5 |
| Cycle 4, Day 1 | 14.0 ± NA | -13.0 ± 1.4 | -16.3 ± 28.4 | -10.0 ± NA | -11.9 ± 15.7 |
| Cycle 5, Day 1 | -2.0 ± NA | -16.0 ± 2.8 | -7.6 ± 24.5 | -11.0 ± 7.1 | -24.6 ± 7.2 |
| Cycle 6, Day 1 | -44.0 ± NA | -19.3 ± 9.2 | -12.8 ± 21.8 | — | -3.4 ± 19.5 |
| Cycle 7, Day 1 | — | -17.3 ± 9.5 | -6.8 ± 12.0 | -2.0 ± NA | -8.3 ± 20.9 |
| Cycle 8, Day 1 | 4.0 ± NA | — | -5.3 ± 27.2 | -6.0 ± NA | -9.4 ± 16.2 |
| Cycle 9, Day 1 | — | -10.0 ± 0.0 | -17.0 ± 46.7 | 6.0 ± NA | 0.6 ± 8.5 |
| Cycle 10, Day 1 | -4.0 ± NA | -2.0 ± NA | -11.3 ± 30.1 | — | 1.0 ± 1.4 |
| Cycle 11, Day 1 | 4.0 ± NA | — | — | 4.0 ± NA | -1.7 ± 12.7 |
| Cycle 12, Day 1 | — | — | -60.0 ± NA | -4.0 ± NA | -5.0 ± 1.4 |
| Cycle 13, Day 1 | -2.0 ± NA | — | -44.0 ± NA | — | 3.0 ± 1.4 |
| Cycle 14, Day 1 | — | — | -54.0 ± NA | — | — |
| Cycle 15, Day 1 | 0.0 ± NA | — | — | — | -10.0 ± NA |
| Cycle 16, Day 1 | — | — | — | — | -2.0 ± NA |
Change from baseline of ECG endpoints QRS interval measured in milliseconds (msec)
| change from baseline msec | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Cycle 2 Day 1 | 0.0 ± 5.7 | -2.0 ± 5.7 | 5.1 ± 11.3 | 0.5 ± 9.6 | 4.8 ± 12.5 |
| Cycle 3, Day 1 | 3.3 ± 7.6 | -2.0 ± 5.7 | -1.3 ± 7.6 | 2.0 ± 3.4 | 1.4 ± 8.2 |
| Cycle 4, Day 1 | 0.0 ± NA | 1.0 ± 1.4 | 2.7 ± 8.8 | -3.3 ± 6.1 | 6.4 ± 16.1 |
| Cycle 5, Day 1 | 8.0 ± NA | -4.0 ± 2.8 | 1.8 ± 9.5 | 2.0 ± 5.7 | -1.4 ± 2.4 |
| Cycle 6, Day 1 | 6.0 ± NA | -2.7 ± 4.2 | -1.8 ± 6.2 | — | 5.4 ± 14.7 |
| Cycle 7, Day 1 | — | -2.7 ± 4.2 | -3.3 ± 7.0 | -10.0 ± NA | -1.5 ± 4.9 |
| Cycle 8, Day 1 | 2.0 ± NA | — | 0.7 ± 2.3 | -8.0 ± NA | 2.6 ± 6.9 |
| Cycle 9, Day 1 | — | -1.0 ± 1.4 | -2.0 ± 8.5 | -6.0 ± NA | 0.0 ± 3.2 |
| Cycle 10, Day 1 | 2.0 ± NA | -4.0 ± NA | -2.3 ± 8.6 | — | 9.5 ± 4.9 |
| Cycle 11, Day 1 | 6.0 ± NA | — | — | -4.0 ± NA | 9.0 ± 7.5 |
| Cycle 12, Day 1 | — | — | -6.0 ± NA | -8.0 ± NA | 10.0 ± 5.7 |
| Cycle 13, Day 1 | 2.0 ± NA | — | -12.0 ± NA | — | 3.5 ± 10.6 |
| Cycle 14, Day 1 | — | — | -10.0 ± NA | — | — |
| Cycle 15, Day 1 | 6.0 ± NA | — | — | — | 8.0 ± NA |
| Cycle 16, Day 1 | — | — | — | — | 7.0 ± NA |
Change from baseline of ECG endpoints QT interval measured in milliseconds (msec)
| change from baseline msec | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Cycle 2 Day 1 | -41.0 ± 94.8 | -5.0 ± 7.1 | 4.5 ± 25.5 | 10.4 ± 50.1 | 14.2 ± 33.7 |
| Cycle 3, Day 1 | 10.0 ± 36.7 | 7.0 ± 29.7 | -15.4 ± 30.6 | -10.7 ± 41.3 | 13.7 ± 41.7 |
| Cycle 4, Day 1 | -60.0 ± NA | 35.0 ± 32.5 | 10.1 ± 22.8 | -12.7 ± 104.3 | -1.4 ± 47.9 |
| Cycle 5, Day 1 | 12.0 ± NA | 13.0 ± 15.6 | 2.2 ± 32.1 | -5.0 ± 26.9 | -27.6 ± 75.5 |
| Cycle 6, Day 1 | 2.0 ± NA | 6.0 ± 26.9 | -11.8 ± 19.1 | — | -3.6 ± 39.3 |
| Cycle 7, Day 1 | — | 29.3 ± 20.0 | 11.8 ± 13.6 | -8.0 ± NA | -8.8 ± 28.3 |
| Cycle 8, Day 1 | 2.0 ± NA | — | 2.0 ± 2.0 | -24.0 ± NA | 0.8 ± 35.5 |
| Cycle 9, Day 1 | — | 37.0 ± 9.9 | -23.0 ± 21.2 | -14.0 ± NA | -24.4 ± 23.0 |
| Cycle 10, Day 1 | 6.0 ± NA | 14.0 ± NA | -18.3 ± 18.6 | — | -6.0 ± 11.3 |
| Cycle 11, Day 1 | 16.0 ± NA | — | — | -22.0 ± NA | 7.0 ± 2.6 |
| Cycle 12, Day 1 | — | — | -4.0 ± NA | -36.0 ± NA | -6.5 ± 27.6 |
| Cycle 13, Day 1 | 20.0 ± NA | — | -40.0 ± NA | — | -15.0 ± 18.4 |
| Cycle 14, Day 1 | — | — | -44.0 ± NA | — | — |
| Cycle 15, Day 1 | 36.0 ± NA | — | — | — | -19.0 ± NA |
| Cycle 16, Day 1 | — | — | — | — | -105.0 ± NA |
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.
| Months | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
|---|---|---|---|---|---|
| Overall Survival (OS) - Phases 1 and 2 | — | — | 3.3 (1.8 to 8.7) | 3.0 (1.8 to 4.7) | 6.9 (1.6 to 12.7) |
Collected over Includes on-treatment events from first dose to within 100 days of last dose. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ulo 600mg+LDAC | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Ulo 800mg+LDAC | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Ulocuplumab 800mg + LDAC 20mg BID | 19/26 (73.1%) | 21/26 (80.8%) | 25/26 (96.2%) |
| Ulocuplumab 1000mg + LDAC 20mg BID | 10/14 (71.4%) | 8/14 (57.1%) | 14/14 (100%) |
| LDAC 20mg BID | 16/22 (72.7%) | 15/22 (68.2%) | 22/22 (100%) |
| Event | Ulo 600mg+LDAC | Ulo 800mg+LDAC | Ulocuplumab 800mg + LDAC 20mg BID | Ulocuplumab 1000mg + LDAC 20mg BID | LDAC 20mg BID |
|---|---|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 2/3 | 0/3 | 8/26 | 5/14 | 6/22 |
| Disseminated intravascular coagulationBlood and lymphatic system disorders | 1/3 | 0/3 | 0/26 | 0/14 | 0/22 |
| Cardiac failureCardiac disorders | 1/3 | 0/3 | 0/26 | 0/14 | 0/22 |
| CataractEye disorders | 1/3 | 0/3 | 0/26 | 0/14 | 0/22 |
| Amylase increasedInvestigations | 1/3 | 0/3 | 0/26 | 0/14 | 0/22 |
| Epstein-Barr virus associated lymphoproliferative disorderNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/3 | 1/3 | 0/26 | 0/14 | 0/22 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/3 | 0/3 | 5/26 | 2/14 | 6/22 |
| SepsisInfections and infestations | 0/3 | 0/3 | 3/26 | 2/14 | 1/22 |
| PneumoniaInfections and infestations | 0/3 | 0/3 | 3/26 | 0/14 | 1/22 |
| DiarrhoeaGastrointestinal disorders | 0/3 | 0/3 | 2/26 | 0/14 | 2/22 |
| Event | Ulo 600mg+LDAC | Ulo 800mg+LDAC | Ulocuplumab 800mg + LDAC 20mg BID | Ulocuplumab 1000mg + LDAC 20mg BID | LDAC 20mg BID |
|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/3 | 3/3 | 11/26 | 3/14 | 8/22 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/3 | 3/3 | 5/26 | 4/14 | 7/22 |
| StomatitisGastrointestinal disorders | 1/3 | 3/3 | 5/26 | 3/14 | 4/22 |
| Platelet count decreasedInvestigations | 2/3 | 3/3 | 6/26 | 4/14 | 8/22 |
| NauseaGastrointestinal disorders | 1/3 | 2/3 | 6/26 | 8/14 | 6/22 |
| Oedema peripheralGeneral disorders | 1/3 | 2/3 | 6/26 | 1/14 | 4/22 |
| PyrexiaGeneral disorders | 2/3 | 2/3 | 8/26 | 5/14 | 5/22 |
| Neutrophil count decreasedInvestigations | 2/3 | 0/3 | 3/26 | 1/14 | 6/22 |
| Back painMusculoskeletal and connective tissue disorders | 2/3 | 0/3 | 0/26 | 4/14 | 0/22 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/3 | 2/3 | 6/26 | 3/14 | 2/22 |
| Age, Continuous(Years) | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 | Total |
|---|---|---|---|---|---|---|
| Mean | 73.7 ± 8.02 | 77.3 ± 1.53 | 74.9 ± 5.4 | 73.1 ± 3.7 | 75.9 ± 5.7 | 74.9 ± 5.21 |
| Age, Customized(Participants) | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 | Total |
|---|---|---|---|---|---|---|
| <70 | 1 | 0 | 4 | 3 | 3 | 11 |
| >=70 | 2 | 3 | 22 | 11 | 21 | 59 |
| Sex: Female, Male(Participants) | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 | Total |
|---|---|---|---|---|---|---|
| Female | 3 | 0 | 9 | 7 | 14 | 33 |
| Male | 0 | 3 | 17 | 7 | 10 | 37 |
| Ethnicity (NIH/OMB)(Participants) | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | — | — | — | — | — | 0 |
| Not Hispanic or Latino | — | — | — | — | — | 0 |
| Unknown or Not Reported | — | — | — | — | — | 0 |
| Race/Ethnicity, Customized(Participants) | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 | Total |
|---|---|---|---|---|---|---|
| White | 0 | 0 | 15 | 4 | 12 | 31 |
| Black/African American | 0 | 0 | 0 | 0 | 0 | 0 |
| Japanese | 3 | 3 | 6 | 6 | 4 | 22 |
| Chinese | 0 | 0 | 2 | 2 | 3 | 7 |
| Asian Indian | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian Other | 0 | 0 | 3 | 0 | 2 | 5 |
| American Indian/Alaskan Native | 0 | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian/Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Other | 0 | 0 | 0 | 1 | 3 | 4 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb