Clinical trial NCT02305563: An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Newly Diagnosed Acute Myeloid Leukemia (AML)
* Considered inappropriate for intensive remission induction therapy by an investigator
* Not eligible for stem cell transplantation

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1
timeFrame: From first dose to end of cycle 1 (28 days)
measure: Number of Participants With Adverse Events (AEs) - Phase 1
timeFrame: From first dose to 30 days post last dose
measure: Number of Participants With >= Grade 3 AEs - Phase 1
timeFrame: From first dose to 30 days post last dose
measure: Number of Participants With AEs Leading to Discontinuation - Phase 1
timeFrame: From first dose to 30 days post last dose
measure: Number of Participants With Serious Adverse Events (SAEs) - Phase 1
timeFrame: From first dose to 30 days post last dose
measure: Number of Deaths - Phase 1
timeFrame: From first dose to 30 days post last dose
measure: Number of Participants With Laboratory Abnormalities - Phase 1
timeFrame: From first dose to 30 days post last dose
measure: Best Overall Response (BOR) - Phase 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
Secondary outcomes:
measure: Best Overall Response (BOR) - Phase 1
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Number of Participants With AEs - Phase 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Number of Participants With AEs Leading to Discontinuation - Phase 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Number of Participants With SAEs - Phase 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Number of Deaths- Phase 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Number of Participants With Laboratory Abnormalities - Phase 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Maximum Observed Serum Concentration (Cmax) - Phases 1 and 2
timeFrame: Cycle 1 Day 1
measure: Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
timeFrame: 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)
measure: Time of Maximum Observed Ulocuplumab Serum Concentration (Tmax) - Phases 1 and 2
timeFrame: Cycle 1 Day 1
measure: Area Under the Ulocuplumab Concentration-time Curve From Time Zero to the Last Quantifiable Concentration [AUC(0-T)] - Phases 1 and 2
timeFrame: Cycle 1 Day 1
measure: Area Under the Ulocuplumab Concentration-time Curve in One Dosing Interval [AUC(TAU)] - Phases 1 and 2
timeFrame: Cycle 1 Day 1
measure: Area Under the Ulocuplumab Concentration-time Curve From Time Zero to Infinity [AUC(INF)] - Phases 1 and 2
timeFrame: 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)
measure: Elimination Half-life (T-HALF) - Phases 1 and 2
timeFrame: 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)
measure: Total Body Clearance of Ulocuplumab (CLT) - Phases 1 and 2
timeFrame: 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)
measure: Volume of Distribution at Steady State (Vss) - Phases 1 and 2
timeFrame: 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)
measure: 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
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: 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
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
measure: Overall Survival (OS) - Phases 1 and 2
timeFrame: From first dose until a minimum follow-up of up to 2 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ucla Center Health Sci
state: California
city: Orlando
country: United States
facility: UF Health Cancer Center at Orlando Health
state: Florida
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Adult Bone Marrow Transplant Clinic
state: North Carolina
city: Cincinnati
country: United States
facility: University Of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Houston
country: United States
facility: The University Of Texas MD Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Froedtert Hospital & Medical College of Wisconsin
state: Wisconsin
city: Curitiba
country: Brazil
facility: Liga Paranaense De Combate Ao Cancer Erasto Gaertner
state: Parana
city: Porto Alegre
country: Brazil
facility: Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Fundacao Pio Xii Hosp Cancer De Barretos
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: IEP Sao Lucas
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Hong Kong
country: China
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
city: Milan
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
city: Roma
country: Italy
facility: Local Institution
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Fukuyama-shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Isehara
country: Japan
facility: Local Institution
state: Kanagawa
city: Hirakata-shi
country: Japan
facility: Local Institution
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Tachikawa
country: Japan
facility: Local Institution
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: New Taipei City
country: Taiwan
facility: Local Institution
city: New Taipei City
country: Taiwan
facility: Local Institution
city: Taoyuan City
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: