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Title:
Phase 2 Study of Azacitidine in Combination with Pembrolizumab in Relapsed/ Refractory Acute Myeloid Leukemia (AML) Patients and in Newly Diagnosed Older ( equal to 65 Years) AML Patients
Protocol Number:
J1651
Phase:
Phase II
Physician:
Ivana Gojo
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
To evaluate the safety of azacitidine and pembrolizumab when administered together in subjects with relapsed/refractory AML or newly diagnosed AML in subjects greater than 65 years of age.
Eligibility:
Cohort 1 - Age 18+. Must have relapsed/refractory AML. If subject has received hypomethylating agents in the past, must have responded to treatment (CR or PR). Subjects who received an allogeneic stem cell transplant will be eligibile 3 months post-transplant.Cohort 2 - Age 65+. Must have newly diagnosed AML. Must not have been previously treated for myelodysplastic syndrome or myeloproliferative neoplasm previously.
Treatment:
Subjects will receive IV pembrolizumab and IV or subcutaneous azacitidine for up to 2 years as long as they have ongoing clinical benefit without evidence of significant toxicity or disease progression.
Population:
Adult
Last Update
03/05/2019 05:03 AM