NCT03204188View on ClinicalTrials.gov

Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 22, 2017

Primary Completion Date

July 18, 2022

Study Completion Date

December 31, 2025

Conditions
B-Cell Chronic Lymphocytic LeukemiaB-Lymphocytic Leukemia, ChronicChronic Lymphocytic LeukemiaLeukemia, Chronic LymphaticLeukemia, Chronic Lymphocytic, B-CellLeukemia, Lymphocytic, ChronicLeukemia, Lymphocytic, Chronic, B-CellLymphocytic Leukemia, Chronic, B CellLymphocytic Leukemia, Chronic, B-Cell
Interventions
DRUG

Ibrutinib

Ibrutinib will be administered daily by mouth starting cycle -3 at 420 mg until end study or disease progression or intolerable side effects occur.

DRUG

Fludarabine

Fludarabine will be administered intravenously only on cycle -2 at 25mg/m\^2 x5 days.

DRUG

Pembrolizumab

Pembrolizumab will be administered intravenously every 3 weeks at 200 mg starting from cycle 1 through cycle 17 or 1 year of immunotherapy phase.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH