An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT02305563 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: CA212-016
• Study Type: interventional
• Target: 70
• Locations: 10 countries
• Sites: 38

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).

Conditions

Leukemia

Outcome Measures

Primary Outcomes (8)

• 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).

  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).

  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).

  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).

  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).

  From first dose to 30 days post last dose

• Number of Deaths - Phase 1

  The number of participants who died.

  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

  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

  From first dose until a minimum follow-up of up to 2 months

Secondary Outcomes (25)

• Best Overall Response (BOR) - Phase 1

  From first dose until a minimum follow-up of up to 2 months

• Number of Participants With AEs - Phase 2

  From first dose until a minimum follow-up of up to 2 months

• Number of Participants With AEs Leading to Discontinuation - Phase 2

  From first dose until a minimum follow-up of up to 2 months

• Number of Participants With SAEs - Phase 2

  From first dose until a minimum follow-up of up to 2 months

• Number of Deaths- Phase 2

  From first dose until a minimum follow-up of up to 2 months

Study Arms (4)

Ulocuplumab + low dose Cytarabine

EXPERIMENTAL

Ulocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment

Drug: BMS-936564; Drug: Cytarabine

Ulocuplumab Dose A + low dose Cytarabine

EXPERIMENTAL

Ulocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort)

Drug: BMS-936564; Drug: Cytarabine

Ulocuplumab Dose B + low dose Cytarabine

EXPERIMENTAL

Ulocuplumab Dose B + low dose Cytarabine Phase 2 (expansion cohort)

Drug: BMS-936564; Drug: Cytarabine

low dose Cytarabine only

OTHER

Low Dose Cytarabine only Phase 2 (expansion cohort)

Drug: BMS-936564; Drug: Cytarabine

Interventions

BMS-936564 DRUG

Also known as: Ulocuplumab, MDX-1338

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (38)

Ucla Center Health Sci

Los Angeles, California, 90095-3075, United States

Location

UF Health Cancer Center at Orlando Health

Orlando, Florida, 32806, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Duke University Adult Bone Marrow Transplant Clinic

Durham, North Carolina, 27705, United States

Location

University Of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

The University Of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Froedtert Hospital & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Liga Paranaense De Combate Ao Cancer Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil

Location

Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Fundacao Pio Xii Hosp Cancer De Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

IEP Sao Lucas

São Paulo, 01236-030, Brazil

Location

Local Institution

São Paulo, 01246-000, Brazil

Location

Local Institution

São Paulo, 05651-901, Brazil

Location

Local Institution

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Local Institution

Hong Kong, China

Location

Local Institution

Jerusalem, 91031, Israel

Location

Local Institution

Tel Aviv, 94239, Israel

Location

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, 95123, Italy

Location

Local Institution

Milan, 20162, Italy

Location

Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli

Napoli, 80131, Italy

Location

Local Institution

Roma, 00133, Italy

Location

Local Institution

Nagoya, Aichi-ken, 4600001, Japan

Location

Local Institution

Fukuyama-shi, Hiroshima, 7200001, Japan

Location

Local Institution

Isehara, Kanagawa, 2591193, Japan

Location

Local Institution

Hirakata-shi, Osaka, 5731191, Japan

Location

Local Institution

Bunkyo-ku, Tokyo, 1138677, Japan

Location

Local Institution

Shinagawa-ku, Tokyo, 1418625, Japan

Location

Local Institution

Shinjuku-Ku, Tokyo, 1608582, Japan

Location

Local Institution

Tachikawa, Tokyo, 1900014, Japan

Location

Local Institution

Bucharest, 020125, Romania

Location

Local Institution

Seoul, 06351, South Korea

Location

Local Institution

Seoul, 06591, South Korea

Location

Local Institution

Kaohsiung City, 833, Taiwan

Location

Local Institution

New Taipei City, 235, Taiwan

Location

Local Institution

New Taipei City, 25173, Taiwan

Location

Local Institution

Taoyuan, 33305, Taiwan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Leukemia

Interventions

ulocuplumab; Cytarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 2, 2014
• Study Start: January 27, 2015
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-08

Locations

BR (6); KR (2); JP (8); IT (4); CN (1); US (9); RO (1); CA (1); IL (2); TW (4)