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Protocol No.1550GCCPrincipal InvestigatorBaer, Maria
PhasePhase II
Age GroupAdult
TitleRandomized Phase II Study to Assess the Role of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Acute Myelogenous Leukemia (AML) Patients After Chemotherapy
DescriptionThis randomized phase II trial studies how well nivolumab works in eliminating any remaining cancer cells and preventing cancer from returning in patients with acute myeloid leukemia that have had signs and symptoms of cancer disappear after receiving chemotherapy. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.
TreatmentExperimental (Arm I): Patients receive nivolumab once every 2 weeks. Treatment repeats every 2 weeks for 46 courses in the absence of disease progression or unacceptable toxicity. OR Observation (Arm II): Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I.
Key EligibilityInclusion Criteria:
-AML patients in first complete remission (CR) (CR1) or first complete remission with incomplete blood count recovery (CRi) after induction and consolidation chemotherapy; except young (< 60 years) AML patients in European LeukemiaNet favorable group
-Within 60 days after bone marrow biopsy confirmed remission after the patients recover from their last course of chemotherapy, the goal will be to consent the eligible patient prior to the remission confirmation bone marrow biopsy at the end of the planned chemotherapy)
-Patient is not a candidate for stem cell transplant due to advanced age or co-morbidities; or the enrollee does not have donor available; or the enrollee declines stem cell transplant due to personal belief; or stem cell transplant is not standard of care based on the risk category of disease
-Life expectancy of greater than 6 months
-Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception
-Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:
-Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier
-Patients receiving any other investigational agents
-Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
-Patients with known central nervous system (CNS) involvement may be excluded
-History of severe hypersensitivity reaction to any monoclonal antibody
-Pregnant women
-Active autoimmune disease or history of autoimmune disease that might recur
-Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration

Please call study site contact for more information.
Applicable Disease SitesAcute Myeloid Leukemia
Therapies InvolvedImmunotherapy
Drugs InvolvedNivolumab
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02275533
ContactGreenebaum Comprehensive Cancer Center: Veronica Kflu, MS Phone:410-328-9416
Pager:
Email:veronica.kflu@umm.edu
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