Nivolumab in AML in Remission at High Risk for Relapse (NCT02532231) | Clinical Trial Compass
CompletedPhase 2
Nivolumab in AML in Remission at High Risk for Relapse
United States15 participantsStarted 2015-10-19
Plain-language summary
This phase II trial studies how well nivolumab works in treating patients with acute myeloid leukemia that has decreased or disappeared but may still be in the body (remission), and is at high risk for returning (relapse). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with AML in remission (defined as CR, CR with incomplete platelet recovery -CRp-, CR with incomplete hematologic recovery -CRi-, or partial remission defined as a bone marrow with \< 10% blasts after therapy with or without hematologic recovery)
* High risk for relapse defined as: 1st CR with high risk features for relapse (including history of prior malignancy treated with chemotherapy or radiotherapy, or history of myelodysplastic syndrome, myeloproliferative disorder, chronic myelomonocytic leukemia, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\] or other hematologic malignancy thought to have evolved to AML \[i.e., secondary AML, (sAML)\]; high risk cytogenetics at diagnosis; fms-related tyrosine kinase 3 \[FLT3\] mutated at diagnosis; or presence or minimal residual disease assessed by polymerase chain reaction \[PCR\], cytogenetics, and/or flow cytometry at time of enrollment) 2nd CR regardless of disease characteristics at the time of diagnosis
* Have received induction chemotherapy and at least one cycle of consolidation chemotherapy; patients should have achieved a CR within 12 months of enrollment onto protocol
* No further chemotherapy or stem cell transplant (SCT) planned at the time of enrollment
* Creatinine =\< 1.5 x upper limit of normal (ULN)
* Serum bilirubin =\< 1.5 x ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
* Eastern Cooperative Oncology Group (ECOG) perfor…