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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Leukemia

Treatments: Drug: BMS-936564; Drug: Cytarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02305563

CA212-016

Details and patient eligibility

About

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).

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 4 patient groups

Ulocuplumab + low dose Cytarabine

Experimental group

Description:

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

Treatment:

Drug: Cytarabine

Drug: BMS-936564

Ulocuplumab Dose A + low dose Cytarabine

Experimental group

Description:

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

Treatment:

Drug: Cytarabine

Drug: BMS-936564

Ulocuplumab Dose B + low dose Cytarabine

Experimental group

Description:

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

Treatment:

Drug: Cytarabine

Drug: BMS-936564

low dose Cytarabine only

Other group

Description:

Low Dose Cytarabine only Phase 2 (expansion cohort)

Treatment:

Drug: Cytarabine

Drug: BMS-936564