Single Agent and Combined Inhibition After Allogeneic Stem Cell Transplant

Conditions

• Acute Myeloid Leukemia and Myelodysplastic Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
  Nivolumab is a fully humanized immunoglobulin 4 (IgG4) monoclonal antibody (mAb) which binds to PD-1 (CD279) with nanomolar affinity and shows a high degree of specificity for PD-1; blocking binding of PD-1 to PD-L1 and PD-L2. Nivolumab binds selectively to human PD-1 and does not bind to other members of the cluster of differentiation protein 28 (CD28) family.
• Ipilimumab — DRUG
  Ipilimumab is a recombinant, human mAb that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). Ipilimumab is an immunoglobulin 1 (IgG1) kappa immunoglobulin with an approximate molecular weight of 148 kilo-Daltons (kDa). Ipilimumab is produced in mammalian (Chinese hamster ovary) cell culture.

Study Details

The purpose of the study is to determine the safety and benefit of nivolumab, ipilimumab or the combination of nivolumab with ipilimumab given after bone marrow transplant for patients with acute myelogenous leukemia and myelodysplastic syndrome.

Key Dates

Start date

Mar 8, 2019

Status verified

Nov 2024

Primary completion

Dec 21, 2023

Completion

Dec 21, 2023

Study Design

Enrollment

8 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group A - Nivolumab
  Nivolumab for 12 doses, on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 * Dose level 1: 1 mg/kg * Dose level 2: 3 mg/kg
• Experimental: Group B - Ipilimumab
  Ipilimumab for 6 doses on day 1 of weeks 1, 4, 7, 10, 13, 16 * Dose level 1: 0.3 mg/kg * Dose level 2: 1.0 mg/kg * Dose level 3: 3.0 mg/kg
• Experimental: Group C - Nivolumab + Ipilimumab
  * Nivolumab 3 mg/kg for 12 doses, on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 * Ipilimumab for 6 doses on day 1 of weeks 1, 4, 7, 10, 13, 16 * Dose level 1: 0.3 mg/kg * Dose level 2: 0.6 mg/kg * Dose level 3: 1.0 mg/kg

Primary Outcome Measure

Safety: The occurrence of at least one treatment-related limiting toxicity defined as a ≥ grade 4 non-hematologic toxicity as specified by the CTCAE 4.0. [ Time Frame: After treatment is initiated through 100 days of discontinuation of dosing. ]

Locations (1)

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