At a glance
ClinicalIndex Comparison Record- ✓Age >18 and <70 years at informed consent
- ✓ECOG Performance Status 0–1
- ✓Histologically or cytologically confirmed recurrent AML with ≥5% myeloblasts in bone marrow
- ✓Prior induction therapy for AML including standard chemotherapy (cytarabine + anthracycline +/- other agents), liposomal cytarabine-daunorubicin, high-dose cytarabine ± fludarabine/cladribine/clofarabine, or >4 cycles of azacitidine/decitabine
- ✕Prior checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or ipilimumab)
- ✕Prior allogeneic stem cell transplant; autologous transplant allowed
- ✕Active CNS leukemia; prior CNS disease allowed if stable for ≥4 weeks, no new/enlarging brain metastases, and off steroids ≥7 days
- ✕Active autoimmune disease requiring systemic treatment in past 2 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
LCCC 1522: Phase 2 Study of High Dose Cytarabine Followed by Pembrolizumab in Relapsed and Refractory Acute Myeloid Leukemia
In Brief
A Phase 2 clinical trial evaluating pembrolizumab, for Acute Myeloid Leukemia, in Relapse. Completed, enrolled 38 participants across 2 sites.
Detailed Summary
Rationale:The purpose of this research study is to test the effectiveness of the standard high dose cytarabine (HiDAC) on days 1 through 5 followed by a single dose of pembrolizumab on day 14 as induction therapy in patients with relapsed and refractory acute myeloid leukemia (AML). Patients who achieve a response to treatment will continue on the study drug (pembrolizumab) every 3 weeks for up to 2 years maintenance therapy. Purpose:This is a study about a new investigative drug, pembrolizumab (MK-3475) that is being studied in a clinical research trial together with standard chemotherapy (HiDAC) in relapsed and refractory AML. The study will also explore the association between potential immune biomarkers and clinical outcomes with pembrolizumab; therefore all patients will have blood and bone marrow samples collected before and after treatment to determine the dynamic nature of immune signatures pre and post-treatment.
Study Details
Timeline
Interventions
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of HiDAC salvage induction chemotherapy. Patients who have a response (i.e., PR/CR/CRi) to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2 years of maintenance therapy (i.e., beginning on day 1 of maintenance).